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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Placebo matching to lorcaserin oral tablet, administered as oral suspension.
Lorcaserin oral tablet, administered as oral suspension.
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.
Time frame: Baseline up to Week 14
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.
Time frame: 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.
Time frame: Baseline up to Week 14
Core Study: Plasma Concentrations of Lorcaserin
Plasma Concentrations of Lorcaserin was evaluated and reported.
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Children's of Alabama / University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
UCSD Rady's Children's Hosptial
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Miami Children's Hospital - Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Neurology, P.A.
Winter Park, Florida, United States
Rare Disease Research Center Pediatrics, LLC
Atlanta, Georgia, United States
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda, Maryland, United States
...and 20 more locations
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)
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.
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)