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

Primary Purpose

Epilepsies, Myoclonic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Lorcaserin
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Myoclonic focused on measuring Dravet Syndrome, Lorcaserin, E2023, Epilepsy, Seizures

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's of Alabama / University of Alabama at BirminghamRecruiting
  • University of California Los Angeles (UCLA)
  • UCSD Rady's Children's Hosptial
  • Children's Hospital ColoradoRecruiting
  • Northwest Florida Clinical Research Group
  • Joe DiMaggio Children's Hospital
  • Miami Children's Hospital - Nicklaus Children's Hospital
  • Pediatric Neurology, P.A.Recruiting
  • Rare Disease Research Center Pediatrics, LLC
  • Mid-Atlantic Epilepsy and Sleep Center - BethesdaRecruiting
  • Spectrum Health/ Helen DeVos Children's Hospital
  • University of Missouri, Department of Child Health, Division of NeurologyRecruiting
  • Institute of Neurology and Neurosurgery at Saint Barnabas
  • Northwell Health - Neuroscience Institute at Great Neck
  • NYU Langone Comprehensive Epilepsy CenterRecruiting
  • New York Medical CollegeRecruiting
  • NorthWell Health - Lennox Hill Hospital
  • University of Rochester Medical Center
  • University of North Carolina
  • Duke University Hospital Center
  • University Hospitals Cleveland Medical CenterRecruiting
  • Children's Hospital of Pittsburgh of UPMC
  • The University of Texas Health Science Center at HoustonRecruiting
  • Seattle Children's Hospital
  • MultiCare Institute for Research & Innovation
  • Alberta Children's HospitalRecruiting
  • Stollery Children's HospitalRecruiting
  • BC Children's Hospital
  • Children's Hospital - VH, London Health Sciences CentreRecruiting
  • University of Toronto Division of Hematology Oncology/The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lorcaserin (Core Study and Open-label Extension Phase)

Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2020
Last Updated
June 27, 2023
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04572243
Brief Title
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
March 5, 2025 (Anticipated)
Study Completion Date
May 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Myoclonic
Keywords
Dravet Syndrome, Lorcaserin, E2023, Epilepsy, Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin (Core Study and Open-label Extension Phase)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to lorcaserin oral tablet, administered as oral suspension.
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Other Intervention Name(s)
E2023
Intervention Description
Lorcaserin oral tablet, administered as oral suspension.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks)
Description
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.
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline
Description
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.
Time Frame
Baseline to Week 14
Title
Percentage of Participants who are Free From Convulsive Seizures in the Core Treatment Period (14 Weeks)
Time Frame
Up to 14 Weeks
Title
Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks)
Time Frame
Up to 14 Weeks
Title
Area Under the Plasma Lorcaserin Concentration-time Curve at Steady-state (AUC,ss) in the Core Treatment Period (14 Weeks)
Time Frame
Up to 14 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants must meet all of the following criteria to be included in this study: Male or female, age 2 years and older at the time of informed consent Diagnosis of epilepsy with Dravet syndrome Has at least 4 convulsive seizures during the 4 weeks of baseline 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: Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions 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 Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors Presence of progressive central nervous system disease other than Dravet syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eisai Medical Information
Phone
1-888-274-2378
Email
esi_medinfo@eisai.com
Facility Information:
Facility Name
Children's of Alabama / University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Terminated
Facility Name
UCSD Rady's Children's Hosptial
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Florida Clinical Research Group
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Terminated
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Miami Children's Hospital - Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Terminated
Facility Name
Pediatric Neurology, P.A.
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Rare Disease Research Center Pediatrics, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Terminated
Facility Name
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Spectrum Health/ Helen DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Terminated
Facility Name
University of Missouri, Department of Child Health, Division of Neurology
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Name
Institute of Neurology and Neurosurgery at Saint Barnabas
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Terminated
Facility Name
Northwell Health - Neuroscience Institute at Great Neck
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Terminated
Facility Name
NYU Langone Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10019-1147
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthWell Health - Lennox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Terminated
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7025
Country
United States
Individual Site Status
Terminated
Facility Name
Duke University Hospital Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Terminated
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Terminated
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Terminated
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Terminated
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
AB T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
Individual Site Status
Recruiting
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital - VH, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Terminated

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Learn more about this trial

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

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