A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome (MOMENTUM 1)
Epilepsies, Myoclonic
About this trial
This is an interventional treatment trial for Epilepsies, Myoclonic focused on measuring Dravet Syndrome, Lorcaserin, E2023, Epilepsy, Seizures
Eligibility 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
Sites / Locations
- Children's of Alabama / University of Alabama at BirminghamRecruiting
- University of California Los Angeles (UCLA)
- UCSD Rady's Children's Hosptial
- Children's Hospital ColoradoRecruiting
- Northwest Florida Clinical Research Group
- Joe DiMaggio Children's Hospital
- Miami Children's Hospital - Nicklaus Children's Hospital
- Pediatric Neurology, P.A.Recruiting
- Rare Disease Research Center Pediatrics, LLC
- Mid-Atlantic Epilepsy and Sleep Center - BethesdaRecruiting
- Spectrum Health/ Helen DeVos Children's Hospital
- University of Missouri, Department of Child Health, Division of NeurologyRecruiting
- Institute of Neurology and Neurosurgery at Saint Barnabas
- Northwell Health - Neuroscience Institute at Great Neck
- NYU Langone Comprehensive Epilepsy CenterRecruiting
- New York Medical CollegeRecruiting
- NorthWell Health - Lennox Hill Hospital
- University of Rochester Medical Center
- University of North Carolina
- Duke University Hospital Center
- University Hospitals Cleveland Medical CenterRecruiting
- Children's Hospital of Pittsburgh of UPMC
- The University of Texas Health Science Center at HoustonRecruiting
- Seattle Children's Hospital
- MultiCare Institute for Research & Innovation
- Alberta Children's HospitalRecruiting
- Stollery Children's HospitalRecruiting
- BC Children's Hospital
- Children's Hospital - VH, London Health Sciences CentreRecruiting
- University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lorcaserin (Core Study and Open-label Extension Phase)
Placebo (Core Study) + Lorcaserin (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.
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.