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Trial record 71 of 215 for:    Lamotrigine

Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy

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ClinicalTrials.gov Identifier: NCT01431963
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : December 3, 2013
Last Update Posted : October 20, 2016
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 Epilepsy
Intervention Drug: Lamictal
Enrollment 70
Recruitment Details A total of 70 participants were enrolled; 3 participants were screened but withdrew from the study before prescription of the first investigational product (67), and only 65 of the participants received at least one dose of the investigational product which comprised the safety population.
Pre-assignment Details The study consisted of a 6-week Escalation Phase, a 24-week Maintenance Phase (MP), a >=2-week Taper Phase, and a post-study examination conducted within 1-4 weeks after the last dose of lamotrigine. In Japan only, the Extension Phase was conducted until either approval for this indication or after 24 months after Last Subject Last Visit in the MP.
Arm/Group Title Lamotrigine
Hide Arm/Group Description In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
Period Title: Overall Study
Started 67
Begin Escalation Phase (EP; 6 Weeks) 67
Received Treatment 65
Complete EP (6 Weeks) 52
Begin Maintenance Phase (MP; 24 Weeks) 52
Complete MP (24 Weeks) 42
Begin Extension Phase (ExP; gt= 24weeks) 19 [1]
Complete ExP (gt= 24 Weeks) 19 [2]
Completed 32
Not Completed 35
Reason Not Completed
Adverse Event             18
Lack of Efficacy             7
Protocol Violation             1
Protocol-defined Stopping Criteria             2
Physician Decision             4
Withdrawal by Subject             3
[1]
Only Japanese participants in ExP,lamotrigine monotherapy was available in Korea. (>=24weeks)
[2]
(>=24 weeks); gt= abbreviation for greater than or equal to
Arm/Group Title Lamotrigine
Hide Arm/Group Description In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
Baseline data were collected in members of the Safety Population, comprised of all participants who had taken at least one dose of investigational product.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
37.3  (20.20)
[1]
Measure Description: Baseline data were collected in members of the Safety Population, comprised of all participants who had taken at least one dose of investigational product.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
26
  40.0%
Male
39
  60.0%
[1]
Measure Description: Baseline data were collected in members of the Safety Population, comprised of all participants who had taken at least one dose of investigational product.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
Asian - East Asian Heritage 26
Asian - Japanese Heritage 39
[1]
Measure Description: Baseline data were collected in members of the Safety Population, comprised of all participants who had taken at least one dose of investigational product.
1.Primary Outcome
Title Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)
Hide Description Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.
Time Frame Weeks 7 to 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants in the Safety Population (SP) who provided at least one set of efficacy data after the first dosing of investigational product. The SP is comprised of all participants who had taken at least one dose of investigational product. Only those participants available at the specified time point were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
All, n=65 28
A+B+C, n=55 22
A+B, n=42 17
C, n=33 23
D5, n=10 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 43.1
Confidence Interval (2-Sided) 95%
30.85 to 55.96
Estimation Comments The estimated value reflects the percentage of participants who were seizure free for all seizures.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 40.0
Confidence Interval (2-Sided) 95%
27.02 to 54.09
Estimation Comments The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 40.5
Confidence Interval (2-Sided) 95%
25.63 to 56.72
Estimation Comments The estimated value reflects the percentage of participants who were seizure free for A+B seizures.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 69.7
Confidence Interval (2-Sided) 95%
51.29 to 84.41
Estimation Comments The estimated value reflects the percentage of participants who were seizure free for C seizures.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 80.0
Confidence Interval (2-Sided) 95%
44.39 to 97.48
Estimation Comments The estimated value reflects the percentage of participants who were seizure free for D5 seizures.
2.Secondary Outcome
Title Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)
Hide Description Time to withdrawal is defined as the time from the start of treatment until withdrawal from the study. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures which affect only a small region of the brain, often the temporal lobes or hippocampi. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.
Time Frame up to Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants available at the specified time point were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 65
Mean (Standard Error)
Unit of Measure: Days
All, n=65 150.0  (8.99)
A+B+C, n=55 148.4  (9.72)
A+B, n=42 147.9  (10.72)
C, n=33 168.0  (10.91)
D5, n=10 14.6  (0.54)
3.Secondary Outcome
Title Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)
Hide Description The time to the first seizure in the Maintenance Phase is measured at the time the first seizure occurred in the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.
Time Frame Weeks 7 to 30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants available at the specified time point were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 52
Mean (Standard Error)
Unit of Measure: Days
All, n=52 103.0  (9.43)
A+B+C, n=44 100.4  (10.44)
A+B, n=34 94.2  (12.22)
C, n=29 113.3  (12.06)
D5, n=8 NA [1]   (NA)
[1]
No participants had D5 seizures in the Maintenance Phase (MP); thus, mean time to the first D5 seizure in the MP could not be calculated.
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from study medication start until the end of treatment (up to Week 54).
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had taken at least one dose of investigational product.
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description In the EP, lamotrigine 25 mg/day was orally administered QD; in the evening(PM) as the initial dose from W1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD(in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, Lamotrigine 200 mg/day was orally administered QD(PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at greater than or equal to 1 week intervals. A dose greater than 200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose less than 100 or greater than 400 mg/day was judged to be necessary, the participant was withdrawn from the study.
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%)
Total   8/65 (12.31%) 
Cardiac disorders   
Sick sinus syndrome  1  1/65 (1.54%) 
Gastrointestinal disorders   
Haemorrhoids  1  1/65 (1.54%) 
Gastrooesophageal reflux disease  1  1/65 (1.54%) 
Intestinal obstruction  1  1/65 (1.54%) 
Injury, poisoning and procedural complications   
Pulmonary contusion  1  1/65 (1.54%) 
Post procedural haemorrhage  1  1/65 (1.54%) 
Investigations   
Electrocardiogram QT prolonged  1  1/65 (1.54%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/65 (1.54%) 
Nervous system disorders   
Epilepsy  1  2/65 (3.08%) 
Skin and subcutaneous tissue disorders   
Stevens-Johnson syndrome  1  1/65 (1.54%) 
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   38/65 (58.46%) 
Gastrointestinal disorders   
Nausea  1  6/65 (9.23%) 
Abdominal pain upper  1  4/65 (6.15%) 
Infections and infestations   
Nasopharyngitis  1  15/65 (23.08%) 
Nervous system disorders   
Headache  1  14/65 (21.54%) 
Dizziness  1  4/65 (6.15%) 
Psychiatric disorders   
Insomnia  1  4/65 (6.15%) 
Skin and subcutaneous tissue disorders   
Rash  1  8/65 (12.31%) 
Drug eruption  1  4/65 (6.15%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01431963     History of Changes
Other Study ID Numbers: 115376
First Submitted: September 1, 2011
First Posted: September 12, 2011
Results First Submitted: September 26, 2013
Results First Posted: December 3, 2013
Last Update Posted: October 20, 2016