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Lorcaserin for Epilepsy (MOMENTUM 1 Trial)

Phase 3
Recruiting
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study
Has at least 4 convulsive seizures during the 4 weeks of baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 weeks
Awards & highlights

MOMENTUM 1 Trial Summary

This trial will compare the effectiveness of lorcaserin to a placebo in reducing convulsive seizures in people with Dravet syndrome.

Who is the study for?
This trial is for males and females aged 2 years or older with Dravet syndrome, a type of epilepsy. Participants must have had at least 4 convulsive seizures in the last month and be on stable antiepileptic drugs. Those who've used lorcaserin recently, taken fenfluramine within the past two months, are on certain serotonergic medications or MAO inhibitors, or have progressive brain diseases besides Dravet can't join.Check my eligibility
What is being tested?
The study aims to see if Lorcaserin helps reduce seizure frequency better than a placebo in those with Dravet syndrome. Patients will receive either Lorcaserin or a placebo alongside their regular antiepileptic medication to compare effectiveness.See study design
What are the potential side effects?
Lorcaserin may cause side effects such as headaches, dizziness, fatigue, nausea, dry mouth and constipation. It might also affect serotonin levels which could lead to mood changes.

MOMENTUM 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My epilepsy medication dose has been stable for the last 4 weeks and will remain so.
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I have had at least 4 convulsive seizures in the last 4 weeks.
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I am at least 2 years old.
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I have been diagnosed with epilepsy that is specifically Dravet syndrome.

MOMENTUM 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks)
Secondary outcome measures
Area Under the Plasma Lorcaserin Concentration-time Curve at Steady-state (AUC,ss) in the Core Treatment Period (14 Weeks)
Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks)
Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline
+1 more

MOMENTUM 1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lorcaserin (Core Study and Open-label Extension Phase)Experimental Treatment1 Intervention
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.
Group II: Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)Placebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorcaserin
2008
Completed Phase 3
~820

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
154,027 Total Patients Enrolled

Media Library

Lorcaserin Clinical Trial Eligibility Overview. Trial Name: NCT04572243 — Phase 3
Myoclonic Epilepsy Research Study Groups: Lorcaserin (Core Study and Open-label Extension Phase), Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
Myoclonic Epilepsy Clinical Trial 2023: Lorcaserin Highlights & Side Effects. Trial Name: NCT04572243 — Phase 3
Lorcaserin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572243 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are signing up to participate in this clinical trial?

"Eisai Inc. is sponsoring a clinical trial that needs 58 patients who fit the eligibility requirements. The trial will be conducted at NorthWell Health in New york, New York and University of Hospital of Cleveland in Cleveland, Ohio."

Answered by AI

Which hospitals are conducting this research?

"There are 28 sites running this trial at the moment. You can find them in New york, Cleveland, Hollywood, and other cities. If you enroll, it might be helpful to pick a location that's closest to you to minimize travel demands."

Answered by AI

Are new participants being accepted for this clinical trial?

"Yes, this study is currently looking for participants according to the website clinicaltrials.gov. This information was last updated on 9/16/2022, and the study was originally posted on 9/23/2020."

Answered by AI

Has the FDA cleared Lorcaserin for public consumption?

"Lorcaserin has received a 3 for safety. This is due to it being a Phase 3 trial, thus having both efficacy and multiple rounds of safety data."

Answered by AI

What is the Lorcaserin research landscape like?

"Lorcaserin was first studied in 2014 at the VA Long Beach medical facility. So far, there have been 18308 completed trials involving this medication. Currently, 3 studies are actively recruiting patients; a large number of these trials are based in New york City."

Answered by AI
~12 spots leftby Mar 2025