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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00355082
First received: July 19, 2006
Last updated: May 9, 2013
Last verified: March 2013
History of Changes
Results First Received: September 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Epilepsy, Partial
Interventions: Drug: lamotrigine, 300 mg/day
Drug: lamotrigine, 250 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 (par.) starting the Continuation phase (CP) does not equal the number completing the Treatment phase (TP), as 1) the CP was optional, 2) not everyone from the TP was eligible to enter the CP, and 3) par. who failed to qualify for the TP (Baseline Failures) were allowed to enter the CP. All par. start the TP at 300 mg/day.

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 1:   Double-Blind (DB) Treatment Phase
    Lamotrigine Extended-release (LTG XR), 300 mg     LTG XR, 250 mg     Baseline Failures  
STARTED     113 [1]   113 [2]   0  
COMPLETED     94     79     0  
NOT COMPLETED     19     34     0  
Adverse Event                 4                 10                 0  
Withdrawal by Subject                 9                 8                 0  
Lack of Efficacy                 6                 7                 0  
Lost to Follow-up                 0                 4                 0  
Protocol Violation                 0                 4                 0  
Pregnancy                 0                 1                 0  
[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 2:   Continuation Phase
    Lamotrigine Extended-release (LTG XR), 300 mg     LTG XR, 250 mg     Baseline Failures  
STARTED     184 [1]   0     11 [2]
COMPLETED     160     0     8  
NOT COMPLETED     24     0     3  
Adverse Event                 2                 0                 1  
Lost to Follow-up                 2                 0                 1  
Protocol Violation                 1                 0                 1  
Withdrawal by Subject                 4                 0                 0  
Lack of Efficacy                 5                 0                 0  
Site Closed by Sponsor                 8                 0                 0  
Scheduling Error                 1                 0                 0  
Ran Out of Drug Due to Travel                 1                 0                 0  
[1] 83 and 101 participants from the 250 and 300 mg groups (DB Phase), respectively, entered the CP.
[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
Total Total of all reporting groups

Baseline Measures
    Treatment Phase: LTG XR, 300 mg     Treatment Phase: LTG XR, 250 mg     Total  
Number of Participants  
[units: participants]
 		  112     111     223  
Age  
[units: years]
Mean ± Standard Deviation 		  33.8  ± 14.3     32.9  ± 12.6     33.4  ± 13.5  
Gender  
[units: participants]
 		     
Female     56     66     122  
Male     56     45     101  
Race/Ethnicity, Customized  
[units: participants]
 		     
African American     5     4     9  
Asian     11     11     22  
Arabic/North African     0     2     2  
White     96     94     190  
Asian - Central/South Asian     0     0     0  
Asian - East Asian     0     0     0  
Number of participants taking indicated concurrent antiepileptic drug at study entry [1]
[units: participants]
 		     
Valproate     73     70     143  
Levetiracetam     11     13     24  
Oxcarbazepine     12     12     24  
Topiramate     12     10     22  
Zonisamide     3     5     8  
Pregabalin     1     1     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 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)   [ Time Frame: From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23) ]
  Show Outcome Measure 1

2.  Secondary:   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)   [ Time Frame: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]
  Show Outcome Measure 2

3.  Secondary:   Time to Discontinuation in the Treatment Phase   [ Time Frame: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Time to Discontinuation in the Treatment Phase
Measure Description Time (days) until the participant discontinued the study
Time Frame From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug

Reporting Groups
  Description
Lamotrigine Extended-release (LTG XR), 300 mg LTG XR, 300 mg/day
LTG XR, 250 mg LTG XR, 250 mg/day

Measured Values
    Lamotrigine Extended-release (LTG XR), 300 mg     LTG XR, 250 mg  
Number of Participants Analyzed  
[units: participants]
 		  112     111  
Time to Discontinuation in the Treatment Phase  
[units: Days]
Mean ± Standard Deviation 		  147.3  ± 31.5     133.2  ± 45.6  

No statistical analysis provided for Time to Discontinuation in the Treatment Phase



4.  Secondary:   Percentage of Participants Meeting Escape Criteria in the Treatment Phase   [ Time Frame: Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]
  Show Outcome Measure 4

5.  Secondary:   Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)   [ Time Frame: Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase   [ Time Frame: The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23) ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase   [ Time Frame: Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase ]
  Show Outcome Measure 7

8.  Secondary:   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)   [ Time Frame: Baseline and entire Continuation phase (24 Weeks) ]
  Show Outcome Measure 8


  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:
unchecked 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.
unchecked 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.


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 by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00355082     History of Changes
Other Study ID Numbers: LAM30055
Study First Received: July 19, 2006
Results First Received: September 8, 2009
Last Updated: May 9, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration