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A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome

NCT04572243 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-08

Study results available
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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

  • Epilepsies, Myoclonic

Interventions

DRUG

Placebo

Placebo matching to lorcaserin oral tablet, administered as oral suspension.

DRUG

Lorcaserin

Lorcaserin oral tablet, administered as oral suspension.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2024-08-15
Completion
2024-08-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572243 on ClinicalTrials.gov