Trials / Completed
CompletedNCT03373383
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 411 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Padsevonil | Padsevonil in different dosages. |
| OTHER | Placebo | Placebo will be provided matching Padsevonil. |
Timeline
- Start date
- 2018-02-12
- Primary completion
- 2020-01-30
- Completion
- 2020-01-30
- First posted
- 2017-12-14
- Last updated
- 2023-12-19
- Results posted
- 2021-04-09
Locations
148 sites across 19 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Lithuania, Mexico, Poland, Portugal, Slovakia, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03373383. Inclusion in this directory is not an endorsement.