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

Sponsor

Eisai Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04572243

Collaborator

(none)

Enrollment

Locations

Arms

32.2

Anticipated Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsies, Myoclonic	Drug: Placebo Drug: Lorcaserin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 23, 2020

Anticipated Primary Completion Date :

Mar 8, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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: Placebo Placebo matching to lorcaserin oral tablet, administered as oral suspension. Drug: Lorcaserin Lorcaserin oral tablet, administered as oral suspension. Other Names: E2023

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: Placebo

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

Drug: Lorcaserin

Lorcaserin oral tablet, administered as oral suspension.

Other Names:

E2023

Outcome Measures

Primary Outcome Measures

Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks) [Baseline to Week 14]
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 [Baseline to Week 14]
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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's of Alabama / University of Alabama at Birmingham	Birmingham	Alabama	United States	35226
2	University of California Los Angeles (UCLA)	Los Angeles	California	United States	90095
3	UCSD Rady's Children's Hosptial	San Diego	California	United States	92123
4	Children's Hospital Colorado	Aurora	Colorado	United States	80045
5	Northwest Florida Clinical Research Group	Gulf Breeze	Florida	United States	32561
6	Joe DiMaggio Children's Hospital	Hollywood	Florida	United States	33021
7	Miami Children's Hospital - Nicklaus Children's Hospital	Miami	Florida	United States	33155
8	Pediatric Neurology, P.A.	Winter Park	Florida	United States	32789
9	Rare Disease Research Center Pediatrics, LLC	Atlanta	Georgia	United States	30318
10	Mid-Atlantic Epilepsy and Sleep Center - Bethesda	Bethesda	Maryland	United States	20817
11	Spectrum Health/ Helen DeVos Children's Hospital	Grand Rapids	Michigan	United States	49503
12	University of Missouri, Department of Child Health, Division of Neurology	Columbia	Missouri	United States	65201
13	Institute of Neurology and Neurosurgery at Saint Barnabas	Livingston	New Jersey	United States	07039
14	Northwell Health - Neuroscience Institute at Great Neck	New Hyde Park	New York	United States	10075
15	NYU Langone Comprehensive Epilepsy Center	New York	New York	United States	10016
16	New York Medical College	New York	New York	United States	10019-1147
17	NorthWell Health - Lennox Hill Hospital	New York	New York	United States	11021
18	University of Rochester Medical Center	Rochester	New York	United States	14642
19	University of North Carolina	Chapel Hill	North Carolina	United States	27599-7025
20	Duke University Hospital Center	Durham	North Carolina	United States	27710
21	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
22	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224
23	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
24	Seattle Children's Hospital	Seattle	Washington	United States	98105
25	MultiCare Institute for Research & Innovation	Tacoma	Washington	United States	98405
26	Alberta Children's Hospital	Calgary	Alberta	Canada	AB T3B 6A8
27	Stollery Children's Hospital	Edmonton	Alberta	Canada	T6G 1C9
28	BC Children's Hospital	Vancouver	British Columbia	Canada	V6H 3N1
29	Children's Hospital - VH, London Health Sciences Centre	London	Ontario	Canada	N6A 4G5
30	University of Toronto Division of Hematology Oncology/The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8