Trials / Completed
CompletedNCT02408523
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- UCB BIOSCIENCES, Inc. · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
Summary
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lacosamide Tablet | * Active Substance: Lacosamide * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use |
| DRUG | Lasosamide Oral Solution | * Active Substance: Lacosamide * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use |
| OTHER | Placebo Tablet | * Active Substance: Placebo * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use |
| OTHER | Placebo Oral Solution | * Active Substance: Placebo * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2019-04-01
- Completion
- 2019-06-01
- First posted
- 2015-04-03
- Last updated
- 2020-12-17
- Results posted
- 2020-04-16
Locations
115 sites across 22 countries: United States, Australia, Belgium, Brazil, Bulgaria, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Taiwan
Source: ClinicalTrials.gov record NCT02408523. Inclusion in this directory is not an endorsement.