Clinical Evaluation of BW430C in Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00395694
First received: November 2, 2006
Last updated: April 11, 2013
Last verified: September 2012
Results First Received: August 16, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: lamictal

  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
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
Adults: LTG Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
Adolescents: LTG Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).

Participant Flow for 2 periods

Period 1:   Escalation Phase + Maintenance Phase
    Adults: LTG     Adolescents: LTG  
STARTED     51     51  
COMPLETED     50     49  
NOT COMPLETED     1     2  
Adverse Event                 1                 2  

Period 2:   Continuation Phase
    Adults: LTG     Adolescents: LTG  
STARTED     49 [1]   48 [1]
COMPLETED     34     35  
NOT COMPLETED     15     13  
Adverse Event                 1                 0  
Lack of Efficacy                 12                 11  
Withdrawal Due to Wishes of Family                 1                 0  
Poor Compliance                 1                 0  
Withdrawal by Subject                 0                 2  
[1] One participant completing the Escalation/Maintenance Phase did not start the Continuation Phase.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Adults: LTG Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
Adolescents: LTG Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
Total Total of all reporting groups

Baseline Measures
    Adults: LTG     Adolescents: LTG     Total  
Number of Participants  
[units: participants]
  51     51     102  
Age  
[units: Years]
Mean ± Standard Deviation
  29.0  ± 9.9     8.2  ± 4.1     18.6  ± 12.9  
Gender  
[units: Participants]
     
Female     23     25     48  
Male     28     26     54  
Race/Ethnicity, Customized  
[units: participants]
     
Asian–Japanese     51     51     102  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Rash Event (Including Stevens–Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment   [ Time Frame: 8 weeks ]

2.  Secondary:   Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment   [ Time Frame: 8 weeks ]

3.  Secondary:   Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment   [ Time Frame: 8 weeks ]

4.  Secondary:   Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment   [ Time Frame: 8 weeks ]

5.  Secondary:   Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures   [ Time Frame: 8 weeks ]

6.  Secondary:   Percent Change in Seizure Frequency of the Indicated Types of Seizures   [ Time Frame: Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14) ]

7.  Secondary:   Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase   [ Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14) ]

8.  Secondary:   Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase   [ Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14) ]

9.  Secondary:   Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase   [ Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14) ]

10.  Secondary:   Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase   [ Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14) ]

11.  Secondary:   Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA   [ Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14) ]

12.  Secondary:   Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8   [ Time Frame: Week 4 and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00395694     History of Changes
Other Study ID Numbers: LAM107844
Study First Received: November 2, 2006
Results First Received: August 16, 2012
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare