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

This study has been completed.

Study NCT00355082 Information provided by GlaxoSmithKline

First Received: July 19, 2006 Last Updated: October 15, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition:	Epilepsy, Partial
Interventions:	Drug: lamotrigine, 250 mg/day Drug: lamotrigine, 300 mg/day

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants in the Treatment phase and all Baseline Failure participants are eligible to enter the Continuation phase. The Continuation phase is for long-term safety exposure to lamotrigine extended release (LTG XR) at 300 mg/day; it is not a cross-over phase.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The number of participants starting the Continuation phase (CP) does not equal the number of participants completing the Treatment phase (TP) because 1) the CP was optional, 2) not everyone from the TP was eligible to enter the CP, and 3) participants who failed to qualify for the TP (Baseline Failures) were allowed to enter the CP.

Reporting Groups

	Description
Lamotrigine Extended-release (LTG XR), 300 mg	LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
LTG XR, 250 mg	LTG XR, 250 mg/day
Baseline Failures	Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day

Participant Flow for 2 periods

Period: Double-Blind Treatment Phase

	Lamotrigine Extended-release (LTG XR), 300 mg	LTG XR, 250 mg
STARTED	113^[1]	113^[2]
COMPLETED	94	79
NOT COMPLETED	19	34
Adverse Event	4	10
Withdrawal by Subject	9	8
Lack of Efficacy	6	7
Lost to Follow-up	0	4
Protocol Violation	0	4
Pregnancy	0	1

[1]	112 participants have baseline data; 1 participant did not receive study drug.
[2]	111 participants have baseline data; 2 participants did not receive study drug.

Period: Continuation Phase

	Lamotrigine Extended-release (LTG XR), 300 mg	Baseline Failures
STARTED	184^[1]	11^[2]
COMPLETED	160	8
NOT COMPLETED	24	3
Adverse Event	2	1
Lost to Follow-up	2	1
Protocol Violation	1	1
Withdrawal by Subject	4	0
Lack of Efficacy	5	0
Site Closed by Sponsor	8	0
Scheduling Error	1	0
Ran Out of Drug Due to Travel	1	0

[1]	See "Pre-assign. Details" for reasons why number starting CP does not equal number completing TP.
[2]	See "Pre-assign. Details" for reasons why number starting CP does not equal number completing TP.

Baseline Characteristics

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Reporting Groups

	Description
Treatment Phase: LTG XR, 300 mg	LTG XR, 300 mg/day in the Treatment phase
Treatment Phase: LTG XR, 250 mg	LTG XR, 250 mg/day in the Treatment phase
Continuation Phase: LTG XR, 300 mg	Treatment phase participants; LTG XR, 300 mg/day
Continuation Phase: Baseline Failures	Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day

Baseline Measures

	Treatment Phase: LTG XR, 300 mg	Treatment Phase: LTG XR, 250 mg	Continuation Phase: LTG XR, 300 mg	Continuation Phase: Baseline Failures	Total
Number of Participants [units: participants]	112	111	184	11	418
Age [units: years] Mean ± Standard Deviation	33.8 ± 14.3	32.9 ± 12.6	32.7 ± 13.4	40.6 ± 15.9	33.4 ± 13.5
Gender [units: participants]
Female	56	66	96	4	222
Male	56	45	88	7	196
Race/Ethnicity, Customized [units: participants]
African American	5	4	4	0	13
Asian	11	11	0	0	22
Arabic/North African	0	2	2	0	4
White	96	94	162	7	359
Asian - Central/South Asian	0	0	0	1	1
Asian - East Asian	0	0	16	3	19
Number of participants taking indicated concurrent antiepileptic drug at study entry^[1] [units: participants]
Valproate	73	70	0	0	143
Levetiracetam	11	13	0	0	24
Oxcarbazepine	12	12	0	0	24
Topiramate	12	10	0	0	22
Zonisamide	3	5	0	0	8
Pregabalin	1	1	0	0	2

[1]	Antiepileptic drug (AED) being taken by participant at study entry; this characteristic is not applicable for the Continuation phase

Outcome Measures

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1. Primary:

The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 and Visit 9 of the Treatment Phase [ From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23) ]

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2. Secondary:

The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 and Visit 9 of the Treatment Phase [ From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]

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3. Secondary:

Time to Discontinuation in the Treatment Phase [ Study Visit 3 through Visit 9 of the Treatment phase (Week 0 through end of study) ]

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4. Secondary:

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) ]

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5. Secondary:

Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 and 9 of the Treatment Phase [ Study Visit 3 through Visit 9 of the Treatment phase (Week 0 through end of study) ]

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6. Secondary:

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) ]

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7. Secondary:

Percent Change From Baseline in the Average Seizure Frequency at the End of the Continuation Phase [ Start of Continuation phase through Week 24 of Continuation ]

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8. Secondary:

The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of the Continuation Phase [ Entire Continuation phase (24 Weeks) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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Results Point of Contact:

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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LAM30055
Study First Received:	July 19, 2006
Results First Received:	September 8, 2009
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00355082 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation; United States: Food and Drug Administration