Trials / Terminated
TerminatedNCT03739840
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (actual)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Padsevonil | Padsevonil in different dosages. |
| DRUG | Placebo | Placebo will be provided matching padsevonil. |
Timeline
- Start date
- 2019-03-06
- Primary completion
- 2020-09-28
- Completion
- 2020-09-28
- First posted
- 2018-11-14
- Last updated
- 2022-12-21
- Results posted
- 2021-10-25
Locations
141 sites across 28 countries: United States, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03739840. Inclusion in this directory is not an endorsement.