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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 is a Phase 3 study of Epilepsy, Tonic-Clonic that has completed, run by GlaxoSmithKline. The registered enrollment target is 153 participants. The trial reports 20 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00104416
The ClinicalTrials.gov registry entry for NCT00104416 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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