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

Eisai

Status and phase: Terminated; Phase 3

Conditions: Epilepsies, Myoclonic

Treatments: Drug: Lorcaserin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04572243

E2023-A001-304

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Lorcaserin (Core Study and Open-label Extension Phase)

Experimental group

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.

Treatment:

Drug: Lorcaserin

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

Placebo Comparator group

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.

Treatment:

Drug: Placebo

Drug: Lorcaserin