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

Epilepsies, Myoclonic Clinical Trial

— MOMENTUM 1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04572243
• Other study ID #: E2023-A001-304
• Status: Recruiting
• Phase: Phase 3
• Start date: September 23, 2020
• Est. completion date: May 28, 2025

Study information

• Verified date: June 2023
• Source: Eisai Inc.
• Contact: Eisai Medical Information
• Phone: 1-888-274-2378
• Email: esi_medinfo[@]eisai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: May 28, 2025
• Est. primary completion date: March 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Key Inclusion Criteria:

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 Key Exclusion Criteria:

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

Related Conditions & MeSH terms

• Epilepsies, Myoclonic
• Epilepsy

Intervention

Drug:
• Placebo
Placebo matching to lorcaserin oral tablet, administered as oral suspension.
• Lorcaserin
Lorcaserin oral tablet, administered as oral suspension.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Children's Hospital - VH, London Health Sciences Centre	London	Ontario
Canada	University of Toronto Division of Hematology Oncology/The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
United States	Rare Disease Research Center Pediatrics, LLC	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Mid-Atlantic Epilepsy and Sleep Center - Bethesda	Bethesda	Maryland
United States	Children's of Alabama / University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Missouri, Department of Child Health, Division of Neurology	Columbia	Missouri
United States	Duke University Hospital Center	Durham	North Carolina
United States	Spectrum Health/ Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Northwest Florida Clinical Research Group	Gulf Breeze	Florida
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Institute of Neurology and Neurosurgery at Saint Barnabas	Livingston	New Jersey
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	Miami Children's Hospital - Nicklaus Children's Hospital	Miami	Florida
United States	Northwell Health - Neuroscience Institute at Great Neck	New Hyde Park	New York
United States	New York Medical College	New York	New York
United States	NorthWell Health - Lennox Hill Hospital	New York	New York
United States	NYU Langone Comprehensive Epilepsy Center	New York	New York
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	UCSD Rady's Children's Hosptial	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	Pediatric Neurology, P.A.	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks)	Seizure frequency will be based on number of seizures per 28 days, calculated during the baseline period and 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.	Baseline to Week 14
Secondary	Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline	A 50 percent (%) responder is defined as a participant with at least 50% reduction in frequency of convulsive seizures per 28 days compared to baseline.	Baseline to Week 14
Secondary	Percentage of Participants who are Free From Convulsive Seizures in the Core Treatment Period (14 Weeks)		Up to 14 Weeks
Secondary	Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks)		Up to 14 Weeks
Secondary	Area Under the Plasma Lorcaserin Concentration-time Curve at Steady-state (AUC,ss) in the Core Treatment Period (14 Weeks)		Up to 14 Weeks