A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome (MOMENTUM 1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsies, Myoclonic
• Intervention / Treatment: Drug: Lorcaserin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Eisai Medical Information; Phone Number: 1-888-274-2378; Email: esi_medinfo@eisai.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, AB T3B 6A8
      • Terminated
      • Alberta Children's Hospital
    • Edmonton, Alberta, Canada, T6G 1C9
      • Recruiting
      • Stollery Children's Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Not yet recruiting
      • BC Children's Hospital
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • Recruiting
      • Children's Hospital - VH, London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 1X8
      • Terminated
      • University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35226
      • Recruiting
      • Children's of Alabama / University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90095
      • Terminated
      • University of California Los Angeles (UCLA)
    • San Diego, California, United States, 92123
      • Not yet recruiting
      • UCSD Rady's Children's Hosptial
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Terminated
      • Northwest Florida Clinical Research Group
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • Joe DiMaggio Children's Hospital
    • Miami, Florida, United States, 33155
      • Terminated
      • Miami Children's Hospital - Nicklaus Children's Hospital
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Pediatric Neurology, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Terminated
      • Rare Disease Research Center Pediatrics, LLC
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Mid-Atlantic Epilepsy and Sleep Center - Bethesda
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Terminated
      • Spectrum Health/ Helen DeVos Children's Hospital
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Recruiting
      • University of Missouri, Department of Child Health, Division of Neurology
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Terminated
      • Institute of Neurology and Neurosurgery at Saint Barnabas
  • New York
    • New Hyde Park, New York, United States, 10075
      • Terminated
      • Northwell Health - Neuroscience Institute at Great Neck
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Comprehensive Epilepsy Center
    • New York, New York, United States, 10019-1147
      • Recruiting
      • New York Medical College
    • New York, New York, United States, 11021
      • Terminated
      • NorthWell Health - Lennox Hill Hospital
    • Rochester, New York, United States, 14642
      • Terminated
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7025
      • Terminated
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Terminated
      • Duke University Hospital Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Terminated
      • Children's Hospital of Pittsburgh of UPMC
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
  • Washington
    • Seattle, Washington, United States, 98105
      • Terminated
      • Seattle Children's Hospital
    • Tacoma, Washington, United States, 98405
      • Terminated
      • MultiCare Institute for Research & Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lorcaserin (Core Study and Open-label Extension Phase); Participants will be randomized to receive lorcaserin administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to less than (<) 20, 20 to <40, and greater than or equal to (>=) 40 kilogram (kg) will be 5, 10, and 20 milligram per day (mg/day) respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.	Drug: Lorcaserin; Lorcaserin oral tablet, administered as oral suspension.; Other Names: E2023
Placebo Comparator: Placebo (Core Study) + Lorcaserin (Open-label Extension Phase); Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to <20, 20 to <40, and >=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.	Drug: Lorcaserin; Lorcaserin oral tablet, administered as oral suspension.; Other Names: E2023; Drug: Placebo; Placebo matching to lorcaserin oral tablet, administered as oral suspension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of Participants who are Free From Convulsive Seizures in the Core Treatment Period (14 Weeks)		Up to 14 Weeks
Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks)		Up to 14 Weeks
Area Under the Plasma Lorcaserin Concentration-time Curve at Steady-state (AUC,ss) in the Core Treatment Period (14 Weeks)		Up to 14 Weeks

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Estimated): March 5, 2025
• Study Completion (Estimated): May 28, 2025

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Epilepsy; Seizures; Dravet Syndrome; Lorcaserin; E2023
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epileptic Syndromes; Epilepsy; Epilepsies, Myoclonic
• Other Study ID Numbers: E2023-A001-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No