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Trial record 50 of 215 for:    Lamotrigine

A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -

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ClinicalTrials.gov Identifier: NCT00566020
Recruitment Status : Completed
First Posted : November 30, 2007
Results First Posted : July 27, 2011
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Intervention Drug: BW430C (lamotrigine)
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine - Dosage Adjustment Phase Lamotrigine - Long-term Administration Phase
Hide Arm/Group Description Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Period Title: 6-week Dosage Adjustment Phase
Started 92 0
Completed 85 0
Not Completed 7 0
Reason Not Completed
Adverse Event             5             0
Lack of Efficacy             2             0
Period Title: 46-week Long-term Administration Phase
Started 0 85
Completed 0 68
Not Completed 0 17
Reason Not Completed
Adverse Event             0             7
Physician Decision             0             7
Lost to Follow-up             0             2
Protocol-defined Stopping Criteria             0             1
Arm/Group Title Lamotrigine
Hide Arm/Group Description Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
43.5  (12.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
52
  56.5%
Male
40
  43.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
Asian - Japanese Heritage 91
Asian - East Asian Heritage 1
1.Primary Outcome
Title Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.
Time Frame From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of study medication
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Participants with any SAE 13
Participants with any non-serious AE 75
2.Primary Outcome
Title Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)
Hide Description Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L.
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
ALP, High, Week 0; n=92 1
ALP, Normal, Week 0; n=92 89
ALP, Low, Week 0; n=92 2
ALP, High, Week 6; n=84 2
ALP, Normal, Week 6; n=84 82
ALP, Low, Week 6; n=84 0
ALP, High, Week 16; n=78 3
ALP, Normal, Week 16; n=78 74
ALP, Low, Week 16; n=78 1
ALP, High, Week 28; n=77 1
ALP, Normal, Week 28; n=77 76
ALP, Low, Week 28; n=77 0
ALP, High, Week 40; n=70 3
ALP, Normal, Week 40; n=70 66
ALP, Low, Week 40; n=70 1
ALP, High, Week 52/EW; n=86 4
ALP, Normal, Week 52/EW; n=86 81
ALP, Low, Week 52/EW; n=86 1
ALT, High, Week 0; n=92 6
ALT, Normal, Week 0; n=92 86
ALT, Low, Week 0; n=92 0
ALT, High, Week 6; n=84 2
ALT, Normal, Week 6; n=84 82
ALT, Low, Week 6; n=84 0
ALT, High, Week 16; n=78 3
ALT, Normal, Week 16; n=78 75
ALT, Low, Week 16; n=78 0
ALT, High, Week 28; n=77 4
ALT, Normal, Week 28; n=77 73
ALT, Low, Week 28; n=77 0
ALT, High, Week 40; n=70 3
ALT, Normal, Week 40; n=70 67
ALT, Low, Week 40; n=70 0
ALT, High, Week 52/EW; n=86 3
ALT, Normal, Week 52/EW; n=86 83
ALT, Low, Week 52/EW; n=86 0
AST, High, Week 0; n=92 3
AST, Normal, Week 0; n=92 89
AST, Low, Week 0; n=92 0
AST, High, Week 6; n=84 2
AST, Normal, Week 6; n=84 82
AST, Low, Week 6; n=84 0
AST, High, Week 16; n=78 2
AST, Normal, Week 16; n=78 76
AST, Low, Week 16; n=78 0
AST, High, Week 28; n=77 2
AST, Normal, Week 28; n=77 75
AST, Low, Week 28; n=77 0
AST, High, Week 40; n=70 3
AST, Normal, Week 40; n=70 67
AST, Low, Week 40; n=70 0
AST, High, Week 52/EW; n=86 3
AST, Normal, Week 52/EW; n=86 83
AST, Low, Week 52/EW; n=86 0
GGT, High, Week 0; n=92 5
GGT, Normal, Week 0; n=92 87
GGT, Low, Week 0; n=92 0
GGT, High, Week 6; n=84 3
GGT, Normal, Week 6; n=84 81
GGT, Low, Week 6; n=84 0
GGT, High, Week 16; n=78 4
GGT, Normal, Week 16; n=78 74
GGT, Low, Week 16; n=78 0
GGT, High, Week 28; n=77 5
GGT, Normal, Week 28; n=77 72
GGT, Low, Week 28; n=77 0
GGT, High, Week 40; n=70 4
GGT, Normal, Week 40; n=70 66
GGT, Low, Week 40; n=70 0
GGT, High, Week 52/EW; n=86 5
GGT, Normal, Week 52/EW; n=86 81
GGT, Low, Week 52/EW; n=86 0
LDH, High, Week 0; n=92 4
LDH, Normal, Week 0; n=92 84
LDH, Low, Week 0; n=92 4
LDH, High, Week 6; n=84 4
LDH, Normal, Week 6; n=84 77
LDH, Low, Week 6; n=84 3
LDH, High, Week 16; n=78 2
LDH, Normal, Week 16; n=78 73
LDH, Low, Week 16; n=78 3
LDH, High, Week 28; n=77 3
LDH, Normal, Week 28; n=77 72
LDH, Low, Week 28; n=77 2
LDH, High, Week 40; n=70 3
LDH, Normal, Week 40; n=70 64
LDH, Low, Week 40; n=70 3
LDH, High, Week 52/EW; n=86 3
LDH, Normal, Week 52/EW; n=86 82
LDH, Low, Week 52/EW; n=86 1
3.Primary Outcome
Title Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW
Hide Description Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L.
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Total bilirubin, High, Week 0; n=92 5
Total bilirubin, Normal, Week 0; n=92 87
Total bilirubin, Low, Week 0; n=92 0
Total bilirubin, High, Week 6; n=84 5
Total bilirubin, Normal, Week 6; n=84 79
Total bilirubin, Low, Week 6; n=84 0
Total bilirubin, High, Week 16; n=78 2
Total bilirubin, Normal, Week 16; n=78 76
Total bilirubin, Low, Week 16; n=78 0
Total bilirubin, High, Week 28; n=77 3
Total bilirubin, Normal, Week 28; n=77 74
Total bilirubin, Low, Week 28; n=77 0
Total bilirubin, High, Week 40; n=70 4
Total bilirubin, Normal, Week 40; n=70 66
Total bilirubin, Low, Week 40; n=70 0
Total bilirubin, High, Week 52/EW; n=86 8
Total bilirubin, Normal, Week 52/EW; n=86 78
Total bilirubin, Low, Week 52/EW; n=86 0
Creatinine, High, Week 0; n=92 2
Creatinine, Normal, Week 0; n=92 86
Creatinine, Low, Week 0; n=92 4
Creatinine, High, Week 6; n=84 2
Creatinine, Normal, Week 6; n=84 81
Creatinine, Low, Week 6; n=84 1
Creatinine, High, Week 16; n=78 4
Creatinine, Normal, Week 16; n=78 72
Creatinine, Low, Week 16; n=78 2
Creatinine, High, Week 28; n=77 2
Creatinine, Normal, Week 28; n=77 73
Creatinine, Low, Week 28; n=77 2
Creatinine, High, Week 40; n=70 2
Creatinine, Normal, Week 40; n=70 66
Creatinine, Low, Week 40; n=70 2
Creatinine, High, Week 52/EW; n=86 3
Creatinine, Normal, Week 52/EW; n=86 79
Creatinine, Low, Week 52/EW; n=86 4
4.Primary Outcome
Title Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW
Hide Description Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter [MMOL/L]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14.
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Calcium, High, Week 0; n=92 1
Calcium, Normal, Week 0; n=92 91
Calcium, Low, Week 0; n=92 0
Calcium, High, Week 6; n=84 4
Calcium, Normal, Week 6; n=84 80
Calcium, Low, Week 6; n=84 0
Calcium, High, Week 16; n=78 2
Calcium, Normal, Week 16; n=78 75
Calcium, Low, Week 16; n=78 1
Calcium, High, Week 28; n=77 1
Calcium, Normal, Week 28; n=77 76
Calcium, Low, Week 28; n=77 0
Calcium, High, Week 40; n=70 1
Calcium, Normal, Week 40; n=70 69
Calcium, Low, Week 40; n=70 0
Calcium, High, Week 52/EW; n=86 0
Calcium, Normal, Week 52/EW; n=86 85
Calcium, Low, Week 52/EW; n=86 1
Cholesterol, High, Week 0; n=92 21
Cholesterol, Normal, Week 0; n=92 66
Cholesterol, Low, Week 0; n=92 5
Cholesterol, High, Week 6; n=84 20
Cholesterol, Normal, Week 6; n=84 57
Cholesterol, Low, Week 6; n=84 7
Cholesterol, High, Week 16; n=78 16
Cholesterol, Normal, Week 16; n=78 58
Cholesterol, Low, Week 16; n=78 4
Cholesterol, High, Week 28; n=77 13
Cholesterol, Normal, Week 28; n=77 61
Cholesterol, Low, Week 28; n=77 3
Cholesterol, High, Week 40; n=70 20
Cholesterol, Normal, Week 40; n=70 45
Cholesterol, Low, Week 40; n=70 5
Cholesterol, High, Week 52/EW; n=86 18
Cholesterol, Normal, Week 52/EW; n=86 64
Cholesterol, Low, Week 52/EW; n=86 4
Chloride, High, Week 0; n=92 2
Chloride, Normal Week 0; n=92 90
Chloride, Low, Week 0; n=92 0
Chloride, High, Week 6; n=84 0
Chloride, Normal, Week 6; n=84 84
Chloride, Low, Week 6; n=84 0
Chloride, High, Week 16; n=78 0
Chloride, Normal, Week 16; n=78 77
Chloride, Low, Week 16; n=78 1
Chloride, High, Week 28; n=77 0
Chloride, Normal, Week 28; n=77 76
Chloride, Low, Week 28; n=77 1
Chloride, High, Week 40; n=70 2
Chloride, Normal, Week 40; n=70 66
Chloride, Low, Week 40; n=70 2
Chloride, High, Week 52/EW; n=86 3
Chloride, Normal, Week 52/EW; n=86 79
Chloride, Low, Week 52/EW; n=86 4
Potassium, High, Week 0; n=92 0
Potassium, Normal, Week 0; n=92 92
Potassium, Low, Week 0; n=92 0
Potassium, High, Week 6; n=84 1
Potassium, Normal, Week 6; n=84 83
Potassium, Low, Week 6; n=84 0
Potassium, High, Week 16; n=78 2
Potassium, Normal, Week 16; n=78 76
Potassium, Low, Week 16; n=78 0
Potassium, High, Week 28; n=77 0
Potassium, Normal, Week 28; n=77 76
Potassium, Low, Week 28; n=77 1
Potassium, High, Week 40; n=70 2
Potassium, Normal, Week 40; n=70 68
Potassium, Low, Week 40; n=70 0
Potassium, High, Week 52/EW; n=86 0
Potassium, Normal, Week 52/EW; n=86 86
Potassium, Low, Week 52/EW; n=86 0
Sodium, High, Week 0; n=92 1
Sodium, Normal, Week 0; n=92 90
Sodium, Low, Week 0; n=92 1
Sodium, High, Week 6; n=84 0
Sodium, Normal, Week 6; n=84 83
Sodium, Low, Week 6; n=84 1
Sodium, High, Week 16; n=78 0
Sodium, Normal, Week 16; n=78 77
Sodium, Low, Week 16; n=78 1
Sodium, High, Week 28; n=77 0
Sodium, Normal, Week 28; n=77 76
Sodium, Low, Week 28; n=77 1
Sodium, High, Week 40; n=70 0
Sodium, Normal, Week 40; n=70 69
Sodium, Low, Week 40; n=70 1
Sodium, High, Week 52/EW; n=86 1
Sodium, Normal, Week 52/EW; n=86 83
Sodium, Low, Week 52/EW; n=86 2
Triglycerides, High, Week 0; n=92 23
Triglycerides, Normal, Week 0; n=92 55
Triglycerides, Low, Week 0; n=92 14
Triglycerides, High, Week 6; n=84 20
Triglycerides, Normal, Week 6; n=84 50
Triglycerides, Low, Week 6; n=84 14
Triglycerides, High, Week 16; n=78 20
Triglycerides, Normal, Week 16; n=78 50
Triglycerides, Low, Week 16; n=78 8
Triglycerides, High, Week 28; n=77 23
Triglycerides, Normal, Week 28; n=77 42
Triglycerides, Low, Week 28; n=77 12
Triglycerides, High, Week 40; n=70 18
Triglycerides, Normal, Week 40; n=70 40
Triglycerides, Low, Week 40; n=70 12
Triglycerides, High, Week 52/EW; n=86 21
Triglycerides, Normal, Week 52/EW; n=86 53
Triglycerides, Low, Week 52/EW; n=86 12
Urea/BUN, High, Week 0; n=92 4
Urea/BUN, Normal, Week 0; n=92 77
Urea/BUN, Low, Week 0; n=92 11
Urea/BUN, High, Week 6; n=84 1
Urea/BUN, Normal, Week 6; n=84 74
Urea/BUN, Low, Week 6; n=84 9
Urea/BUN, High, Week 16; n=78 5
Urea/BUN, Normal, Week 16; n=78 68
Urea/BUN, Low, Week 16; n=78 5
Urea/BUN, High, Week 28; n=77 2
Urea/BUN, Normal, Week 28; n=77 73
Urea/BUN, Low, Week 28; n=77 2
Urea/BUN, High, Week 40; n=70 5
Urea/BUN, Normal, Week 40; n=70 56
Urea/BUN, Low, Week 40; n=70 9
Urea/BUN, High, Week 52/EW; n=86 5
Urea/BUN, Normal, Week 52/EW; n=86 74
Urea/BUN, Low, Week 52/EW; n=86 7
5.Primary Outcome
Title Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW
Hide Description Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L.
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Platelet count, High, Week 0; n=92 3
Platelet count, Normal, Week 0; n=92 89
Platelet count, Low, Week 0; n=92 0
Platelet count, High, Week 6; n=84 2
Platelet count, Normal, Week 6; n=84 81
Platelet count, Low, Week 6; n=84 1
Platelet count, High, Week 16; n=78 2
Platelet count, Normal, Week 16; n=78 75
Platelet count, Low, Week 16; n=78 1
Platelet count, High, Week 28; n=77 2
Platelet count, Normal, Week 28; n=77 75
Platelet count, Low, Week 28; n=77 0
Platelet count, High, Week 40; n=68 0
Platelet count, Normal, Week 40; n=68 68
Platelet count, Low, Week 40; n=68 0
Platelet count, High, Week 52/EW; n=86 3
Platelet count, Normal, Week 52/EW; n=86 82
Platelet count, Low, Week 52/EW; n=86 1
White blood cell count, High, Week 0; n=92 7
White blood cell count, Normal, Week 0; n=92 83
White blood cell count, Low, Week 0; n=92 2
White blood cell count, High, Week 6; n=84 1
White blood cell count, Normal, Week 6; n=84 81
White blood cell count, Low, Week 6; n=84 2
White blood cell count, High, Week 16; n=78 1
White blood cell count, Normal, Week 16; n=78 75
White blood cell count, Low, Week 16; n=78 2
White blood cell count, High, Week 28; n=77 2
White blood cell count, Normal, Week 28; n=77 70
White blood cell count, Low, Week 28; n=77 5
White blood cell count, High, Week 40; n=69 3
White blood cell count, Normal, Week 40; n=69 61
White blood cell count, Low, Week 40; n=69 5
White blood cell count, High, Week 52/EW; n=86 3
White blood cell count, Normal, Week 52/EW; n=86 80
White blood cell count, Low, Week 52/EW; n=86 3
6.Primary Outcome
Title Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW
Hide Description Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452.
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Total protein, High, Week 0; n=92 1
Total protein, Normal, Week 0; n=92 85
Total protein, Low, Week 0; n=92 6
Total protein, High, Week 6; n=84 0
Total protein, Normal, Week 6; n=84 77
Total protein, Low, Week 6; n=84 7
Total protein, High, Week 16; n=78 0
Total protein, Normal, Week 16; n=78 74
Total protein, Low, Week 16; n=78 4
Total protein, High, Week 28; n=77 0
Total protein, Normal, Week 28; n=77 69
Total protein, Low, Week 28; n=77 8
Total protein, High, Week 40; n=70 1
Total protein, Normal, Week 40; n=70 64
Total protein, Low, Week 40; n=70 5
Total protein, High, Week 52/EW; n=86 0
Total protein, Normal, Week 52/EW; n=86 72
Total protein, Low, Week 52/EW; n=86 14
Hemoglobin, High, Week 0; n=92 4
Hemoglobin, Normal, Week 0; n=92 80
Hemoglobin, Low, Week 0; n=92 8
Hemoglobin, High, Week 6; n=84 2
Hemoglobin, Normal, Week 6; n=84 75
Hemoglobin, Low, Week 6; n=84 7
Hemoglobin, High, Week 16; n=78 3
Hemoglobin, Normal, Week 16; n=78 68
Hemoglobin, Low, Week 16; n=78 7
Hemoglobin, High, Week 28; n=77 1
Hemoglobin, Normal, Week 28; n=77 69
Hemoglobin, Low, Week 28; n=77 7
Hemoglobin, High, Week 40; n=69 1
Hemoglobin, Normal, Week 40; n=69 62
Hemoglobin, Low, Week 40; n=69 6
Hemoglobin, High, Week 52/EW; n=86 4
Hemoglobin, Normal, Week 52/EW; n=86 71
Hemoglobin, Low, Week 52/EW; n=86 11
Hematocrit, High, Week 0; n=92 4
Hematocrit, Normal, Week 0; n=92 83
Hematocrit, Low, Week 0; n=92 5
Hematocrit, High, Week 6; n=84 3
Hematocrit, Normal, Week 6; n=84 75
Hematocrit, Low, Week 6; n=84 6
Hematocrit, High, Week 16; n=78 2
Hematocrit, Normal, Week 16; n=78 73
Hematocrit, Low, Week 16; n=78 3
Hematocrit, High, Week 28; n=77 3
Hematocrit, Normal, Week 28; n=77 69
Hematocrit, Low, Week 28; n=77 5
Hematocrit, High, Week 40; n=69 4
Hematocrit, Normal, Week 40; n=69 63
Hematocrit, Low, Week 40; n=69 2
Hematocrit, High, Week 52/EW; n=86 3
Hematocrit, Normal, Week 52/EW; n=86 73
Hematocrit, Low, Week 52/EW; n=86 10
7.Primary Outcome
Title Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW
Hide Description Red blood cell count was measured in participants at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10^12)/L, Female: 3.76-5.16 TI/L.
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Red blood cell count, High, Week 0; n=92 2
Red blood cell count, Normal, Week 0; n=92 88
Red blood cell count, Low, Week 0; n=92 2
Red blood cell count, High, Week 6; n=84 1
Red blood cell count, Normal, Week 6; n=84 78
Red blood cell count, Low, Week 6; n=84 5
Red blood cell count, High, Week 16; n=78 1
Red blood cell count, Normal, Week 16; n=78 73
Red blood cell count, Low, Week 16; n=78 4
Red blood cell count, High, Week 28; n=77 1
Red blood cell count, Normal, Week 28; n=77 70
Red blood cell count, Low, Week 28; n=77 6
Red blood cell count, High, Week 40; n=69 1
Red blood cell count, Normal, Week 40; n=69 64
Red blood cell count, Low, Week 40; n=69 4
Red blood cell count, High, Week 52/EW; n=86 3
Red blood cell count, Normal, Week 52/EW; n=86 72
Red blood cell count, Low, Week 52/EW; n=86 11
8.Primary Outcome
Title Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Description Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG [-]), trace (TRA [+/-]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Urine Glucose, Week 0, NEG [-]; n=92 88
Urine Glucose, Week 0, TRA [+/-]; n=92 1
Urine Glucose, Week 0, 1+; n=92 1
Urine Glucose, Week 0, 2+; n=92 1
Urine Glucose, Week 0, 3+; n=92 0
Urine Glucose, Week 0, 4+; n=92 1
Urine Glucose, Week 0, 5+; n=92 0
Urine Glucose, Week 6, NEG [-]; n=84 81
Urine Glucose, Week 6, TRA [+/-]; n=84 0
Urine Glucose, Week 6, 1+; n=84 1
Urine Glucose, Week 6, 2+; n=84 1
Urine Glucose, Week 6, 3+; n=84 1
Urine Glucose, Week 6, 4+; n=84 0
Urine Glucose, Week 6, 5+; n=84 0
Urine Glucose, Week 16, NEG [-]; n=78 77
Urine Glucose, Week 16, TRA [+/-]; n=78 0
Urine Glucose, Week 16, 1+; n=78 1
Urine Glucose, Week 16, 2+; n=78 0
Urine Glucose, Week 16, 3+; n=78 0
Urine Glucose, Week 16, 4+; n=78 0
Urine Glucose, Week 16, 5+; n=78 0
Urine Glucose, Week 28, NEG [-]; n=77 76
Urine Glucose, Week 28, TRA [+/-]; n=77 1
Urine Glucose, Week 28, 1+; n=77 0
Urine Glucose, Week 28, 2+; n=77 0
Urine Glucose, Week 28, 3+; n=77 0
Urine Glucose, Week 28, 4+; n=77 0
Urine Glucose, Week 28, 5+; n=77 0
Urine Glucose, Week 40, NEG [-]; n=70 68
Urine Glucose, Week 40, TRA [+/-]; n=70 2
Urine Glucose, Week 40, 1+; n=70 0
Urine Glucose, Week 40, 2+; n=70 0
Urine Glucose, Week 40, 3+; n=70 0
Urine Glucose, Week 40, 4+; n=70 0
Urine Glucose, Week 40, 5+; n=70 0
Urine Glucose, Week 52/EW, NEG [-]; n=86 85
Urine Glucose, Week 52/EW, TRA [+/-]; n=86 0
Urine Glucose, Week 52/EW, 1+; n=86 1
Urine Glucose, Week 52/EW, 2+; n=86 0
Urine Glucose, Week 52/EW, 3+; n=86 0
Urine Glucose, Week 52/EW, 4+; n=86 0
Urine Glucose, Week 52/EW, 5+; n=86 0
Urine Protein, Week 0, NEG [-]; n=92 87
Urine Protein, Week 0, TRA [+/-]; n=92 3
Urine Protein, Week 0, 1+; n=92 1
Urine Protein, Week 0, 2+; n=92 1
Urine Protein, Week 0, 3+; n=92 0
Urine Protein, Week 0, 4+; n=92 0
Urine Protein, Week 0, 5+; n=92 0
Urine Protein, Week 6, NEG [-]; n=84 81
Urine Protein, Week 6, TRA [+/-]; n=84 1
Urine Protein, Week 6, 1+; n=84 2
Urine Protein, Week 6, 2+; n=84 0
Urine Protein, Week 6, 3+; n=84 0
Urine Protein, Week 6, 4+; n=84 0
Urine Protein, Week 6, 5+; n=84 0
Urine Protein, Week 16, NEG [-]; n=78 76
Urine Protein, Week 16, TRA [+/-]; n=78 0
Urine Protein, Week 16, 1+; n=78 1
Urine Protein, Week 16, 2+; n=78 1
Urine Protein, Week 16, 3+; n=78 0
Urine Protein, Week 16, 4+; n=78 0
Urine Protein, Week 16, 5+; n=78 0
Urine Protein, Week 28, NEG [-]; n=77 75
Urine Protein, Week 28, TRA [+/-]; n=77 0
Urine Protein, Week 28, 1+; n=77 2
Urine Protein, Week 28, 2+; n=77 0
Urine Protein, Week 28, 3+; n=77 0
Urine Protein, Week 28, 4+; n=77 0
Urine Protein, Week 28, 5+; n=77 0
Urine Protein, Week 40, NEG [-]; n=70 69
Urine Protein, Week 40, TRA [+/-]; n=70 0
Urine Protein, Week 40, 1+; n=70 0
Urine Protein, Week 40, 2+; n=70 1
Urine Protein, Week 40, 3+; n=70 0
Urine Protein, Week 40, 4+; n=70 0
Urine Protein, Week 40, 5+; n=70 0
Urine Protein, Week 52/EW, NEG [-]; n=86 81
Urine Protein, Week 52/EW, TRA [+/-]; n=86 1
Urine Protein, Week 52/EW, 1+; n=86 3
Urine Protein, Week 52/EW, 2+; n=86 1
Urine Protein, Week 52/EW, 3+; n=86 0
Urine Protein, Week 52/EW, 4+; n=86 0
Urine Protein, Week 52/EW, 5+; n=86 0
Urine Urobilinogen, Week 0, NEG [-]; n=92 0
Urine Urobilinogen, Week 0, TRA [+/-]; n=92 88
Urine Urobilinogen, Week 0, 1+; n=92 4
Urine Urobilinogen, Week 0, 2+; n=92 0
Urine Urobilinogen, Week 0, 3+; n=92 0
Urine Urobilinogen, Week 0, 4+; n=92 0
Urine Urobilinogen, Week 0, 5+; n=92 0
Urine Urobilinogen, Week 6, NEG [-]; n=84 0
Urine Urobilinogen, Week 6, TRA [+/-]; n=84 81
Urine Urobilinogen, Week 6, 1+; n=84 2
Urine Urobilinogen, Week 6, 2+; n=84 1
Urine Urobilinogen, Week 6, 3+; n=84 0
Urine Urobilinogen, Week 6, 4+; n=84 0
Urine Urobilinogen, Week 6, 5+; n=84 0
Urine Urobilinogen, Week 16, NEG [-]; n=78 0
Urine Urobilinogen, Week 16, TRA [+/-]; n=78 76
Urine Urobilinogen, Week 16, 1+; n=78 2
Urine Urobilinogen, Week 16, 2+; n=78 0
Urine Urobilinogen, Week 16, 3+; n=78 0
Urine Urobilinogen, Week 16, 4+; n=78 0
Urine Urobilinogen, Week 16, 5+; n=78 0
Urine Urobilinogen, Week 28, NEG [-]; n=77 0
Urine Urobilinogen, Week 28, TRA [+/-]; n=77 77
Urine Urobilinogen, Week 28, 1+; n=77 0
Urine Urobilinogen, Week 28, 2+; n=77 0
Urine Urobilinogen, Week 28, 3+; n=77 0
Urine Urobilinogen, Week 28, 4+; n=77 0
Urine Urobilinogen, Week 28, 5+; n=77 0
Urine Urobilinogen, Week 40, NEG [-]; n=70 0
Urine Urobilinogen, Week 40, TRA [+/-]; n=70 68
Urine Urobilinogen, Week 40, 1+; n=70 2
Urine Urobilinogen, Week 40, 2+; n=70 0
Urine Urobilinogen, Week 40, 3+; n=70 0
Urine Urobilinogen, Week 40, 4+; n=70 0
Urine Urobilinogen, Week 40, 5+; n=70 0
Urine Urobilinogen, Week 52/EW, NEG [-]; n=86 0
Urine Urobilinogen, Week 52/EW, TRA [+/-]; n=86 82
Urine Urobilinogen, Week 52/EW, 1+; n=86 4
Urine Urobilinogen, Week 52/EW, 2+; n=86 0
Urine Urobilinogen, Week 52/EW, 3+; n=86 0
Urine Urobilinogen, Week 52/EW, 4+; n=86 0
Urine Urobilinogen, Week 52/EW, 5+; n=86 0
9.Primary Outcome
Title Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Description Systolic and diastolic blood pressure was measured in participants at the indicated time points.
Time Frame Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
Systolic blood pressure, Week 0; n=92 119.9  (15.40)
Systolic blood pressure, Week 2; n=87 121.7  (16.11)
Systolic blood pressure, Week 4; n=85 118.9  (15.77)
Systolic blood pressure, Week 5; n=85 119.0  (16.26)
Systolic blood pressure, Week 6; n=84 120.4  (16.09)
Systolic blood pressure, Week 8; n=81 118.6  (16.28)
Systolic blood pressure, Week 12; n=79 120.1  (15.71)
Systolic blood pressure, Week 16; n=78 119.1  (16.76)
Systolic blood pressure, Week 20; n=77 117.8  (15.04)
Systolic blood pressure, Week 24; n=77 118.5  (15.30)
Systolic blood pressure, Week 28; n=77 117.3  (18.84)
Systolic blood pressure, Week 32; n=76 121.8  (17.04)
Systolic blood pressure, Week 36; n=73 121.3  (15.80)
Systolic blood pressure, Week 40; n=70 118.2  (15.21)
Systolic blood pressure, Week 44; n=69 118.7  (14.88)
Systolic blood pressure, Week 48; n=69 121.2  (16.37)
Systolic blood pressure, Week 52/EW; n=87 118.2  (14.20)
Diastolic blood pressure, Week 0; n=92 74.2  (11.41)
Diastolic blood pressure, Week 2; n=87 74.9  (11.62)
Diastolic blood pressure, Week 4; n=85 74.2  (12.08)
Diastolic blood pressure, Week 5; n=85 73.8  (12.34)
Diastolic blood pressure, Week 6; n=84 73.7  (11.16)
Diastolic blood pressure, Week 8; n=81 72.6  (12.72)
Diastolic blood pressure, Week 12; n=79 73.2  (12.08)
Diastolic blood pressure, Week 16; n=78 73.0  (12.29)
Diastolic blood pressure, Week 20; n=77 73.6  (11.59)
Diastolic blood pressure, Week 24; n=77 74.2  (11.72)
Diastolic blood pressure, Week 28; n=77 71.1  (12.24)
Diastolic blood pressure, Week 32; n=76 74.0  (11.93)
Diastolic blood pressure, Week 36; n=73 72.4  (10.98)
Diastolic blood pressure, Week 40; n=70 72.3  (12.04)
Diastolic blood pressure, Week 44; n=69 73.0  (12.22)
Diastolic blood pressure, Week 48; n=69 72.7  (11.91)
Diastolic blood pressure, Week 52/EW; n=87 73.2  (11.69)
10.Primary Outcome
Title Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Description Heart rate was measured in participants at the indicated time points.
Time Frame Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: beat per minute
Week 0; n=92 76.3  (12.48)
Week 2; n=87 78.0  (12.77)
Week 4; n=85 77.4  (11.96)
Week 5; n=85 78.5  (12.54)
Week 6; n=84 77.0  (11.97)
Week 8; n=81 76.8  (11.34)
Week 12; n=79 79.0  (13.47)
Week 16; n=78 76.5  (11.81)
Week 20; n=77 77.4  (11.09)
Week 24; n=77 74.9  (12.50)
Week 28; n=77 75.9  (10.28)
Week 32; n=76 77.2  (12.23)
Week 36; n=73 76.8  (11.46)
Week 40; n=70 75.8  (10.63)
Week 44; n=69 77.3  (11.10)
Week 48; n=69 78.2  (11.63)
Week 52/EW; n=87 74.8  (11.75)
11.Primary Outcome
Title Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Description The weight of participants was recorded at the indicated time points.
Time Frame Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: kilograms
Week 0; n=92 60.86  (12.532)
Week 6; n=84 61.62  (12.405)
Week 8; n=81 61.29  (12.420)
Week 12; n=79 61.26  (12.685)
Week 16; n=78 61.38  (12.753)
Week 20; n=77 61.19  (12.929)
Week 24; n=77 61.29  (12.712)
Week 28; n=77 60.99  (12.688)
Week 32; n=76 61.05  (12.840)
Week 36; n=73 61.06  (13.097)
Week 40; n=70 60.67  (13.214)
Week 44; n=69 60.72  (13.214)
Week 48; n=69 60.43  (13.056)
Week 52/EW; n=87 60.09  (12.765)
12.Primary Outcome
Title Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW
Hide Description The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.
Time Frame Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Kilograms per meters squared
Week 0; n=92 22.8  (3.934)
Week 6; n=84 23.01  (3.878)
Week 8; n=81 22.89  (3.863)
Week 12; n=79 22.93  (3.975)
Week 16; n=78 22.96  (3.965)
Week 20; n=77 22.86  (3.941)
Week 24; n=77 22.91  (3.916)
Week 28; n=77 22.80  (3.970)
Week 32; n=76 22.81  (4.016)
Week 36; n=73 22.71  (4.041)
Week 40; n=70 22.48  (3.820)
Week 44; n=69 22.51  (3.785)
Week 48; n=69 22.40  (3.750)
Week 52/EW; n=87 22.42  (3.818)
13.Primary Outcome
Title Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW
Hide Description ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.
Time Frame Weeks 0, 6, 28, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Week 0, Normal; n=92 73
Week 0, Abnormal-NCS; n=92 19
Week 0, Abnormal-CS; n=92 0
Week 0, No result; n=92 0
Week 6, Normal; n=84 69
Week 6, Abnormal-NCS; n=84 15
Week 6, Abnormal-CS; n=84 0
Week 6, No result; n=84 0
Week 28, Normal; n=77 62
Week 28, Abnormal-NCS; n=77 15
Week 28, Abnormal-CS; n=77 0
Week 28, No result; n=77 0
Week 52 (EW), Normal; n=84 68
Week 52 (EW), Abnormal-NCS; n=84 15
Week 52 (EW), Abnormal-CS; n=84 1
Week 52 (EW), No result; n=84 0
14.Secondary Outcome
Title Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Description The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Time Frame Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): participants who received >=1 dose of study medication and underwent >=1 efficacy assessment. Observed Cases (OC; observed data with no imputation) and Last Observation Carried Forward (LOCF; data imputed [replaced] by most recent observed value [compared to planned date of missing observation]) were used for analysis.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 0, LOCF; n=92 2.9  (1.10)
Week 0, OC; n=92 2.9  (1.10)
Week 2, LOCF; n=91 2.6  (1.19)
Week 2, OC; n=87 2.5  (1.13)
Week 4, LOCF; n=92 2.5  (1.17)
Week 4, OC; n=85 2.3  (0.98)
Week 5, LOCF; n=92 2.4  (1.16)
Week 5, OC; n=85 2.2  (0.95)
Week 6, LOCF; n=92 2.3  (1.13)
Week 6, OC; n=84 2.2  (0.89)
Week 8, LOCF; n=92 2.4  (1.16)
Week 8, OC; n=81 2.2  (0.93)
Week 12, LOCF; n=92 2.2  (1.20)
Week 12, OC; n=79 2.0  (0.91)
Week 16, LOCF; n=92 2.3  (1.21)
Week 16, OC; n=78 2.1  (0.94)
Week 20, LOCF; n=92 2.4  (1.22)
Week 20, OC; n=77 2.1  (0.96)
Week 24, LOCF; n=92 2.4  (1.20)
Week 24, OC; n=77 2.2  (0.95)
Week 28, LOCF; n=92 2.3  (1.24)
Week 28, OC; n=77 2.1  (0.99)
Week 32, LOCF; n=92 2.4  (1.19)
Week 32, OC; n=76 2.2  (0.93)
Week 36, LOCF; n=92 2.3  (1.23)
Week 36, OC; n=73 2.0  (0.95)
Week 40, LOCF; n=92 2.4  (1.22)
Week 40, OC; n=70 2.1  (0.95)
Week 44, LOCF; n=92 2.4  (1.23)
Week 44, OC; n=69 2.1  (0.93)
Week 48, LOCF; n=92 2.3  (1.23)
Week 48, OC; n=69 2.0  (0.91)
Week 52/EW, LOCF; n=92 2.1  (1.24)
Week 52/EW, OC; n=87 2.1  (1.25)
15.Secondary Outcome
Title Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Description The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).
Time Frame Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2, LOCF; n=91 -0.3  (0.93)
Week 2, OC; n=87 -0.3  (0.92)
Week 4, LOCF; n=92 -0.4  (1.01)
Week 4, OC; n=85 -0.5  (0.96)
Week 5, LOCF; n=92 -0.5  (1.07)
Week 5, LOCF; n=85 -0.6  (1.03)
Week 6, LOCF; n=92 -0.6  (1.07)
Week 6, OC; n=84 -0.7  (1.02)
Week 8, LOCF; n=92 -0.5  (1.16)
Week 8, LOCF; n=81 -0.6  (1.14)
Week 12, LOCF; n=92 -0.7  (1.23)
Week 12, OC; n=79 -0.8  (1.19)
Week 16, LOCF; n=92 -0.6  (1.21)
Week 16, OC; n=78 -0.7  (1.17)
Week 20, LOCF; n=92 -0.5  (1.17)
Week 20, OC; n=77 -0.6  (1.14)
Week 24, LOCF; n=92 -0.5  (1.09)
Week 24, OC; n=77 -0.6  (1.05)
Week 28, LOCF; n=92 -0.5  (1.23)
Week 28, OC; n=77 -0.7  (1.21)
Week 32, LOCF; n=92 -0.5  (1.14)
Week 32, OC; n=76 -0.6  (1.11)
Week 36, LOCF; n=92 -0.6  (1.18)
Week 36, OC; n=73 -0.7  (1.13)
Week 40, LOCF; n=92 -0.5  (1.24)
Week 40, OC; n=70 -0.6  (1.22)
Week 44, LOCF; n=92 -0.5  (1.16)
Week 44, OC; n=69 -0.6  (1.11)
Week 48, LOCF; n=92 -0.6  (1.19)
Week 48, OC; n=69 -0.7  (1.14)
Week 52/EW, LOCF; n=92 -0.8  (1.19)
Week 52/EW, OC; n=87 -0.8  (1.19)
16.Secondary Outcome
Title Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW
Hide Description The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).
Time Frame Weeks 6, 16, 28, 40, and 52/EW
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Hide Analysis Population Description
FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 91
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6, LOCF; n=91 5.2  (6.68)
Week 6, OC; n=84 4.3  (4.85)
Week 16, LOCF; n=91 6.1  (7.28)
Week 16, OC; n=78 5.2  (6.01)
Week 28, LOCF; n=91 5.5  (6.76)
Week 28, OC; n=77 4.5  (5.13)
Week 40, LOCF; n=91 5.9  (7.21)
Week 40, OC; n=70 4.7  (5.53)
Week 52/EW, LOCF; n=91 5.5  (7.30)
Week 52/EW, OC; n=87 5.4  (7.38)
17.Secondary Outcome
Title Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW
Hide Description The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 91
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6, LOCF; n=91 -4.5  (7.37)
Week 6, OC; n=84 -4.7  (7.19)
Week 16, LOCF; n=91 -3.7  (7.51)
Week 16, OC; n=78 -3.8  (7.51)
Week 28, LOCF; n=91 -4.3  (7.62)
Week 28, OC; n=77 -4.5  (7.66)
Week 40, LOCF; n=91 -3.9  (7.77)
Week 40, OC; n=70 -3.9  (7.69)
Week 52/EW, LOCF; n=91 -4.3  (7.17)
Week 52/EW, OC; n=87 -4.1  (6.96)
18.Secondary Outcome
Title Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW
Hide Description The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst).
Time Frame Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 91
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6, LOCF; n=91 3.2  (6.20)
Week 6, OC; n=84 2.6  (4.37)
Week 16, LOCF; n=91 2.6  (5.83)
Week 16, OC; n=78 1.7  (3.02)
Week 28, LOCF; n=91 2.8  (6.96)
Week 28, OC; n=77 2.0  (5.19)
Week 40, LOCF; n=91 2.7  (6.24)
Week 40, OC; n=70 1.7  (3.95)
Week 52/EW, LOCF; n=91 1.9  (5.55)
Week 52/EW, OC; n=87 2.0  (5.66)
19.Secondary Outcome
Title Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW
Hide Description The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).
Time Frame Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 91
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6, LOCF; n=91 0.2  (6.64)
Week 6, OC; n=84 -0.3  (5.88)
Week 16, LOCF; n=91 -0.4  (7.20)
Week 16, OC; n=78 -1.3  (6.13)
Week 28, LOCF; n=91 -0.2  (6.89)
Week 28, OC; n=77 -1.1  (5.75)
Week 40, LOCF; n=91 -0.3  (7.56)
Week 40, OC; n=70 -1.1  (6.73)
Week 52/EW, LOCF; n=91 -1.1  (7.11)
Week 52/EW, OC; n=87 -1.1  (7.27)
20.Secondary Outcome
Title Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)
Hide Description Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.
Time Frame from Week 6 to Week 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants who took at least one dose of drugs that induce lamotrigine glucuronidation (e.g., carbamazepine) from the date of the first dose of study medication to the date of the last dose.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 1
Median (Full Range)
Unit of Measure: Nanograms per milliliter
1605.70
(0.00 to 3238.6)
21.Secondary Outcome
Title Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)
Hide Description PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.
Time Frame from Week 6 to Week 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants (par.) who took at least one dose of drugs that inhibit lamotrigine glucuronidation (i.e., valproate) from the date of the first dose of study medication to the date of the last dose. A total of 8 par. were analyzed; 1 par. had both 100 and 200 mg data, 4 par. had 100 mg data only, and 3 par. had 200 mg data only.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: Nanograms per milliliter
Lamotrigine 100 mg; n=5
5312.30
(3762.7 to 15107.0)
Lamotrigine 200 mg; n=4
6935.40
(3210.2 to 9300.9)
22.Secondary Outcome
Title Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer
Hide Description PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.
Time Frame from Week 6 to Week 52/EW
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants without concomitant use of inhibitor and inducer from the date of the first dose of study medication to the date of the last dose. Multiple blood samplings were conducted for some participants. A total of 82 participants were analyzed; 4 participants did not have 200 mg dose data but had data for lower doses.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
Overall Number of Participants Analyzed 82
Median (Full Range)
Unit of Measure: Nanograms per milliliter
Lamotrigine 25 mg; n=2
699.95
(527.8 to 872.1)
Lamotrigine 100 mg; n=12
2793.55
(1486.7 to 7440.8)
Lamotrigine 125 mg; n=1
3505.30
(3505.3 to 3505.3)
Lamotrigine 150 mg; n=1
5418.40
(5418.4 to 5418.4)
Lamotrigine 200 mg; n=78
4092.30
(131.0 to 11053.2)
Lamotrigine 225 mg; n=1
3594.25
(2879.3 to 4309.2)
Lamotrigine 300 mg; n=7
5127.10
(3349.4 to 12066.6)
Lamotrigine 400 mg; n=4
8600.40
(4722.2 to 10830.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%)
Total   13/92 (14.13%) 
Cardiac disorders   
Sick sinus syndrome  1  1/92 (1.09%) 
Infections and infestations   
Pharyngitis  1  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Gastric cancer  1  1/92 (1.09%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/92 (1.09%) 
Psychiatric disorders   
Mania  1  4/92 (4.35%) 
Depression  1  2/92 (2.17%) 
Delirium  1  1/92 (1.09%) 
Self injurious behaviour  1  1/92 (1.09%) 
Suicidal ideation  1  1/92 (1.09%) 
Reproductive system and breast disorders   
Ovarian hemorrhage  1  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/92 (1.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lamotrigine
Affected / at Risk (%)
Total   52/92 (56.52%) 
Blood and lymphatic system disorders   
Anemia  1  5/92 (5.43%) 
Gastrointestinal disorders   
Abdominal pain upper  1  14/92 (15.22%) 
Stomatitis  1  11/92 (11.96%) 
Nausea  1  7/92 (7.61%) 
Vomiting  1  7/92 (7.61%) 
Diarrhea  1  6/92 (6.52%) 
Infections and infestations   
Nasopharyngitis  1  36/92 (39.13%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  5/92 (5.43%) 
Nervous system disorders   
Headache  1  6/92 (6.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Tsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao and Atsuko Shinohara. Study SCA106052, a clinical evaluation of BW430C (lamotrigine) in bipolar I disorder - Long-term extension study -. Rinsho seishin igaku. 2011;40(7):981-995.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00566020     History of Changes
Other Study ID Numbers: SCA106052
First Submitted: November 28, 2007
First Posted: November 30, 2007
Results First Submitted: June 30, 2011
Results First Posted: July 27, 2011
Last Update Posted: April 4, 2017