A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome (MOMENTUM 1)
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| ClinicalTrials.gov Identifier: NCT04572243 |
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Recruitment Status :
Recruiting
First Posted : October 1, 2020
Last Update Posted : December 14, 2022
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Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
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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 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 : | September 23, 2020 |
| Estimated Primary Completion Date : | March 5, 2025 |
| Estimated Study Completion Date : | May 28, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
CDKL5 deficiency disorder
Genetic epilepsy with febrile seizures plus
CHD2 myoclonic encephalopathy
Drug Information available for:
Lorcaserin
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Lorcaserin
Lorcaserin oral tablet, administered as oral suspension.
Other Name: E2023 |
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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.
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Drug: Placebo
Placebo matching to lorcaserin oral tablet, administered as oral suspension. Drug: Lorcaserin Lorcaserin oral tablet, administered as oral suspension.
Other Name: E2023 |
Primary Outcome Measures :
- Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 14 Weeks ]
- Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks) [ Time Frame: Up to 14 Weeks ]
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572243
Contacts
| Contact: Eisai Medical Information | 1-888-274-2378 | esi_medinfo@eisai.com |
Locations
Show 30 study locations
Sponsors and Collaborators
Eisai Inc.
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT04572243 |
| Other Study ID Numbers: |
E2023-A001-304 |
| First Posted: | October 1, 2020 Key Record Dates |
| Last Update Posted: | December 14, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Eisai Inc.:
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Dravet Syndrome Lorcaserin E2023 Epilepsy Seizures |
Additional relevant MeSH terms:
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Epilepsy Epilepsies, Myoclonic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Epilepsy, Generalized Epileptic Syndromes |