Trials / Terminated
TerminatedNCT04572243
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo matching to lorcaserin oral tablet, administered as oral suspension. |
| DRUG | Lorcaserin | Lorcaserin oral tablet, administered as oral suspension. |
Timeline
- Start date
- 2020-09-23
- Primary completion
- 2024-08-15
- Completion
- 2024-08-15
- First posted
- 2020-10-01
- Last updated
- 2025-10-08
- Results posted
- 2025-10-08
Locations
30 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04572243. Inclusion in this directory is not an endorsement.