Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Epilepsies, Myoclonic Dravet Syndrome Lorcaserin E2023 Epilepsy Seizures

Eligibility

You can join if…

Open to people ages 2 years and up

Participants must meet all of the following criteria to be included in this study:

  1. Male or female, age 2 years and older at the time of informed consent
  2. Diagnosis of epilepsy with Dravet syndrome
  3. Has at least 4 convulsive seizures during the 4 weeks of baseline
  4. Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study

You CAN'T join if...

Participants who meet any of the following criteria will be excluded from this study:

  1. Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions
  2. Use of fenfluramine within 2 months before screening, any history of lack of fenfluramine efficacy, or any history of valvulopathy at baseline with history of fenfluramine use
  3. Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors
  4. Presence of progressive central nervous system disease other than Dravet syndrome

Locations

  • UCSD Rady's Children's Hosptial not yet accepting patients
    San Diego California 92123 United States
  • University of California Los Angeles (UCLA) not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eisai Inc.
ID
NCT04572243
Phase
Phase 3
Study Type
Interventional
Last Updated