Trials / Completed
CompletedNCT00104416
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures
A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lamotrigine (LAMICTAL) extended-release | Primary experimental dosage form |
| DRUG | Placebo | Placebo control |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2005-03-01
- Last updated
- 2017-01-02
- Results posted
- 2010-05-18
Locations
146 sites across 11 countries: United States, Argentina, Brazil, Chile, Germany, India, Malaysia, Puerto Rico, Russia, South Korea, Ukraine
Source: ClinicalTrials.gov record NCT00104416. Inclusion in this directory is not an endorsement.