Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | September 1, 2011 | ||||
Last Updated Date | June 28, 2012 | ||||
Start Date ICMJE | September 2011 | ||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
• Seizure free rate in the maintenance phase (across seizure types and by seizure type) [ Time Frame: This outcome is measured at the end of the maintenance phase (at Week 30). Seizure free rate: Number of subjects who complete the study and who have not experienced seizures in the maintenance phase / Number of subjects who receive the investigational ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01431963 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy | ||||
Official Title ICMJE | A Multi-center, Uncontrolled, Open-label, Evaluation of Lamotrigine Monotherapy in Newly Diagnosed Epilepsy or Recurrent Epilepsy (Currently Untreated) | ||||
Brief Summary | This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy (currently untreated). The study is composed of baseline, escalation phase, maintenance phase, taper phase and post study examination. During the escalation phase, the investigational product is administered orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2 weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks. However, the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it is confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can be gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As a rule, lamotrigine should be administered once daily (in the evening), but the dose exceeding 200 mg/day can be administered in two divided doses (in the morning and evening). After the completion of maintenance phase, Japanese subjects who have responded to lamotrigine without tolerability issues are eligible to enter an extension phase of the study if indicated, until either approval of this indication (monotherapy in epilepsy) or after 24 months after LSLV (Last Subject's Last Visit) of the maintenance phase, whichever is sooner. |
||||
Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE | Epilepsy | ||||
Intervention ICMJE | Drug: Lamictal
No comparison. |
||||
Study Arm (s) | Experimental: Lamotrigine
No comparison.
Intervention: Drug: Lamictal |
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 60 | ||||
Estimated Completion Date | March 2013 | ||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 16 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
|
||||
Location Countries ICMJE | Japan, Korea, Republic of | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01431963 | ||||
Other Study ID Numbers ICMJE | 115376 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | GlaxoSmithKline | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |