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NCT00104416 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures
A Phase 3 study of Epilepsy, Tonic-Clonic, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT00104416: Completed Phase 3 study of Epilepsy, Tonic-Clonic, sponsored by GlaxoSmithKline.
NCT00104416 is a Phase 3 study of Epilepsy, Tonic-Clonic that has completed, run by GlaxoSmithKline. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00104416, a Phase 3 study of Epilepsy, Tonic-Clonic, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
Primary Outcome
Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG lamotrigine (LAMICTAL) extended-release
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - Santa Monica
- GSK Investigational Site - Sepuldeva
Alabama
- GSK Investigational Site - Anniston
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Northport
- GSK Investigational Site - Tuscaloosa
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Scottsdale
- GSK Investigational Site - Tucson
Florida
- GSK Investigational Site - Hollywood
- GSK Investigational Site - Maitland
- GSK Investigational Site - Ocala
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Augusta
Arkansas
- GSK Investigational Site - Little Rock
District of Columbia
- GSK Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2004-12 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00104416 record still lists
NCT00104416 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Epilepsy, Tonic-Clonic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00104416 names 20 study sites across 7 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00104416 about?
NCT00104416 is a clinical study titled "Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures". This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tab...
What is the current status of trial NCT00104416?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2004-12. Estimated completion is 2008-07.
What conditions does trial NCT00104416 study?
This clinical trial studies the following conditions: Epilepsy, Tonic-Clonic.
What interventions are being tested in trial NCT00104416?
The interventions under investigation include: Placebo (DRUG), lamotrigine (LAMICTAL) extended-release (DRUG).
Who is sponsoring clinical trial NCT00104416?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00104416 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epilepsy, Tonic-Clonic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00104416's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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