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NCT04572243 · ClinicalTrials.gov registry record · Phase 3
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
A Phase 3 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
NCT04572243: Clinical Trial Phase 3 study, sponsored by Eisai.
NCT04572243 is a Phase 3 study that was terminated before completion, run by Eisai. The registered enrollment target is 22 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572243, a Phase 3 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: (\[post-baseline value minus the baseline value\] / baseline value) \*100.
Interventions
- DRUG Placebo
- DRUG Lorcaserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2024-08-15 |
| Phase | Phase 3 |
Why NCT04572243 stopped before completion
NCT04572243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04572243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04572243 about?
NCT04572243 is a clinical study titled "A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome". 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.
What is the current status of trial NCT04572243?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2020-09-23. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT04572243?
The interventions under investigation include: Placebo (DRUG), Lorcaserin (DRUG).
Who is sponsoring clinical trial NCT04572243?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04572243's enrollment target sits among peer trials
22 1953rd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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