Epilepsies, MyoclonicPhase 3MOMENTUM 1NCT04572243

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

A Phase 3 study testing Lorcaserin in people with Epilepsies, Myoclonic, run by Eisai Inc. at 30 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Epilepsies, Myoclonic
What is being tested?: Lorcaserin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 30 sitesin 2 countries
Study dates: 23 Sep 2020to 15 Aug 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

30 sites in 2 countries.

Country

City, postcode or hospital

30 sites in 2 countries

United States25 sites

Rare Disease Research Center Pediatrics, LLC
Atlanta, Georgia, 30318
Children's Hospital Colorado
Aurora, Colorado, 80045
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda, Maryland, 20817
Children's of Alabama / University of Alabama at Birmingham
Birmingham, Alabama, 35226
University of North Carolina
Chapel Hill, North Carolina, 27599-7025
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Missouri, Department of Child Health, Division of Neurology
Columbia, Missouri, 65201
Duke University Hospital Center
Durham, North Carolina, 27710
Spectrum Health/ Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, 32561
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey, 07039
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Miami Children's Hospital - Nicklaus Children's Hospital
Miami, Florida, 33155
Northwell Health - Neuroscience Institute at Great Neck
New Hyde Park, New York, 10075
NYU Langone Comprehensive Epilepsy Center
New York, New York, 10016
New York Medical College
New York, New York, 10019-1147
NorthWell Health - Lennox Hill Hospital
New York, New York, 11021
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
University of Rochester Medical Center
Rochester, New York, 14642
UCSD Rady's Children's Hosptial
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Pediatric Neurology, P.A.
Winter Park, Florida, 32789

Other trials in United States

Canada5 sites

Alberta Children's Hospital
Calgary, Alberta, AB T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9
Children's Hospital - VH, London Health Sciences Centre
London, Ontario, N6A 4G5
University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

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

Conditions: Epilepsies, Myoclonic
Being tested: Placebo, Lorcaserin
Keywords: Dravet Syndrome, Lorcaserin, E2023, Epilepsy, Seizures
Medical subject headings: Epilepsies, Myoclonic, Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo matching to lorcaserin oral tablet, administered as oral suspension.
LorcaserinDrug
Also called E2023
Lorcaserin oral tablet, administered as oral suspension.

Study groups in NCT04572243
Study group	Role	What they receive
Lorcaserin (Core Study and Open-label Extension Phase)	Experimental	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. Receives: Drug: Lorcaserin
Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)	Placebo comparator	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. Receives: Drug: Placebo; Drug: Lorcaserin

What is being measured

The primary outcome is the main question the study is designed to answer.

Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period
Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week 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. Percent change from baseline was calculated as: ([post-baseline value minus the baseline value] / baseline value) *100.
Measured: Baseline up to Week 14

Secondary outcomes (4)

Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline
A responder was defined as a participant who experienced a reduction of 50% or greater in the frequency of convulsive seizures during the 14-week treatment period compared to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) 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.
Measured: Baseline up to Week 14
Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period
A responder was a participant who experienced a 100% reduction (seizure freedom) in convulsive seizure frequency in the 14-week treatment period relative to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) 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.
Measured: Baseline up to Week 14
Core Study: Plasma Concentrations of Lorcaserin
Plasma Concentrations of Lorcaserin was evaluated and reported.
Measured: Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose
Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) that emerges during treatment, was absent at pretreatment (baseline) or reemerges during treatment, was present at pretreatment (baseline) but stopped before treatment or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product.
Measured: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202015 Aug 2024

First posted1 Oct 2020
Study start23 Sep 2020
Primary completion15 Aug 2024
Study completion15 Aug 2024

Why it stopped: The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epilepsies, MyoclonicStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04572243
Sponsor's protocol ID: E2023-A001-304
Acronym: MOMENTUM 1
Status last verified: Jan 2025
First submitted: 30 Sep 2020
Last updated: 8 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
Dravet Syndrome
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingPhase 1/2
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
Dravet Syndrome

All Epilepsies, Myoclonic trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04572243
Acronym / sponsor ID: MOMENTUM 1 / E2023-A001-304
Conditions: Epilepsies, Myoclonic
Keywords: Dravet Syndrome, Lorcaserin, E2023, Epilepsy, Seizures
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.
Enrolment: 22 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: 23 Sep 2020 (actual)
Primary completion: 15 Aug 2024 (actual)
Study completion: 15 Aug 2024 (actual)
First posted: 1 Oct 2020 (actual)
Results: Posted 8 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lorcaserin (Core Study and Open-label Extension Phase)	Experimental	Drug: LorcaserinParticipants 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.
Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)	Placebo comparator	Drug: Placebo, Drug: LorcaserinParticipants 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.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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 (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo matching to lorcaserin oral tablet, administered as oral suspension.	Drug	Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
LorcaserinAlso: E2023Lorcaserin oral tablet, administered as oral suspension.	Drug	Lorcaserin (Core Study and Open-label Extension Phase), Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)

Primary outcome

Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period
Time frame: Baseline up to Week 14
Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week 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. Percent change from baseline was calculated as: ([post-baseline value minus the baseline value] / baseline value) *100.

4 secondary outcomes

Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline
Time frame: Baseline up to Week 14
Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period
Time frame: Baseline up to Week 14
Core Study: Plasma Concentrations of Lorcaserin
Time frame: Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose
Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18)

Results and safety

Results posted to the registry on 8 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Core Study: Placebo	11	8
Core Study: Lorcaserin	11	7
Extension Phase: Placebo Then Lorcaserin	0	0
Extension Phase: Lorcaserin	0	0

Primary outcome: Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period

Time frame: Baseline up to Week 14. Median (Full Range). Unit: percent change

Measure	Core Study: Placebo n = 10	Core Study: Lorcaserin n = 10
Value	18.78 (-53.7 to 131.5)	-78.88 (-100.0 to 542.9)

Core Study: Placebo vs Core Study: Lorcaserin: Median Difference (Final Values): -86.08 (95% CI -144.01 to -28.14)

Population analysed: The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Core Study: Placebo	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Core Study: Lorcaserin	1 of 11 (9.1%)	8 of 11 (72.7%)	0 of 11
Extension Phase: Placebo Then Lorcaserin	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Extension Phase: Lorcaserin	1 of 7 (14.3%)	3 of 7 (42.9%)	0 of 7

Limitations and caveats (from the sponsor): This study was terminated due to sponsor decision, and not due to safety concerns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Related trials for Epilepsies, Myoclonic

RecruitingPhase 1/2
ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
Dravet Syndrome
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingPhase 1/2
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
Dravet Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

30 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lorcaserin in people with Epilepsies, Myoclonic, run by Eisai Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period (time frame: Baseline up to Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.