Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

Phase 3

Completed

• Conditions: Epilepsy, Partial
• Interventions: Drug: lamotrigine, 300 mg/day; Drug: lamotrigine, 250 mg/day

• Registration Number: NCT00355082
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.

Detailed Description

The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-21
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-09-08
• Results First Submitted QC: 2009-10-15
• Results First Posted: 2009-11-25
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lamotrigine 300	lamotrigine, 300 mg/day	300 mg/day treatment
lamotrigine 250	lamotrigine, 250 mg/day	250 mg/day treatment

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)	From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)	The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.

Secondary Outcome Measures

Name	Time	Method
Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase	The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)	The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn
The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)	From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)	The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.
Time to Discontinuation in the Treatment Phase	From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)	Time (days) until the participant discontinued the study
Percentage of Participants Meeting Escape Criteria in the Treatment Phase	Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)	The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.
Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)	Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)	Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.
Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase	Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase	Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.
The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)	Baseline and entire Continuation phase (24 Weeks)	Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇦 Zaporizhzhya, Ukraine