Clinical trial NCT04572243: A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsies, Myoclonic
Keywords: Dravet Syndrome
Lorcaserin
E2023
Epilepsy
Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-01
Enrollment: 28
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks)
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline
timeFrame: Baseline to Week 14
measure: Percentage of Participants who are Free From Convulsive Seizures in the Core Treatment Period (14 Weeks)
timeFrame: Up to 14 Weeks
measure: Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks)
timeFrame: Up to 14 Weeks
measure: Area Under the Plasma Lorcaserin Concentration-time Curve at Steady-state (AUC,ss) in the Core Treatment Period (14 Weeks)
timeFrame: Up to 14 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama / University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: San Diego
country: United States
facility: UCSD Rady's Children's Hosptial
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Gulf Breeze
country: United States
facility: Northwest Florida Clinical Research Group
state: Florida
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital - Nicklaus Children's Hospital
state: Florida
city: Winter Park
country: United States
facility: Pediatric Neurology, P.A.
state: Florida
city: Atlanta
country: United States
facility: Rare Disease Research Center Pediatrics, LLC
state: Georgia
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center - Bethesda
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health/ Helen DeVos Children's Hospital
state: Michigan
city: Columbia
country: United States
facility: University of Missouri, Department of Child Health, Division of Neurology
state: Missouri
city: Livingston
country: United States
facility: Institute of Neurology and Neurosurgery at Saint Barnabas
state: New Jersey
city: New Hyde Park
country: United States
facility: Northwell Health - Neuroscience Institute at Great Neck
state: New York
city: New York
country: United States
facility: NYU Langone Comprehensive Epilepsy Center
state: New York
city: New York
country: United States
facility: New York Medical College
state: New York
city: New York
country: United States
facility: NorthWell Health - Lennox Hill Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: London
country: Canada
facility: Children's Hospital - VH, London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
state: Ontario
Study officials:
References: