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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Bipolar Disorder
Intervention:	Drug: BW430C (lamotrigine)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lamotrigine - 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
Lamotrigine - 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

Participant Flow for 2 periods

Period 1: 6-week Dosage Adjustment Phase

	Lamotrigine - Dosage Adjustment Phase	Lamotrigine - Long-term Administration Phase
STARTED	92	0
COMPLETED	85	0
NOT COMPLETED	7	0
Adverse Event	5	0
Lack of Efficacy	2	0

Period 2: 46-week Long-term Administration Phase

	Lamotrigine - Dosage Adjustment Phase	Lamotrigine - Long-term Administration Phase
STARTED	0	85
COMPLETED	0	68
NOT COMPLETED	0	17
Adverse Event	0	7
Physician Decision	0	7
Lost to Follow-up	0	2
Protocol-defined Stopping Criteria	0	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Lamotrigine	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

Baseline Measures

	Lamotrigine
Number of Participants [units: participants]	92
Age [units: Years] Mean ± Standard Deviation	43.5 ± 12.11
Gender [units: Participants]
Female	52
Male	40
Race/Ethnicity, Customized [units: participants]
Asian - Japanese Heritage	91
Asian - East Asian Heritage	1

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event [ Time Frame: From baseline (Week 0) until 2 weeks after the end of treatment (Week 54) ]

Show Outcome Measure 1

2. Primary:

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) [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW) ]

Show Outcome Measure 2

3. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 3

4. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 4

5. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 5

6. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 6

7. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 7

8. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 8

9. Primary:

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 [ 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 ]

Show Outcome Measure 9

10. Primary:

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 [ 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 ]

Show Outcome Measure 10

11. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW ]

Show Outcome Measure 11

12. Primary:

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 [ Time Frame: Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW ]

Show Outcome Measure 12

13. Primary:

Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW [ Time Frame: Weeks 0, 6, 28, and 52/EW ]

Show Outcome Measure 13

14. Secondary:

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 [ Time Frame: Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW ]

Show Outcome Measure 14

15. Secondary:

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 [ 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 ]

Show Outcome Measure 15

16. Secondary:

Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW [ Time Frame: Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 16

17. Secondary:

Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 17

18. Secondary:

Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW [ Time Frame: Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 18

19. Secondary:

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW [ Time Frame: Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW ]

Show Outcome Measure 19

20. Secondary:

Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection) [ Time Frame: from Week 6 to Week 52/EW ]

Show Outcome Measure 20

21. Secondary:

Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection) [ Time Frame: from Week 6 to Week 52/EW ]

Show Outcome Measure 21

22. Secondary:

Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer [ Time Frame: from Week 6 to Week 52/EW ]

Show Outcome Measure 22

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00566020 History of Changes
Other Study ID Numbers:	SCA106052
Study First Received:	November 28, 2007
Results First Received:	June 30, 2011
Last Updated:	August 4, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare