Phase
Condition
Epilepsy
Unverricht-lundborg Syndrome
Treatment
Lorcaserin
Placebo
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 weeksbefore screening, and be expected to remain stable throughout the study
Exclusion
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 beingdiscontinued due to lack of efficacy or adverse reactions
Use of fenfluramine within 2 months before screening, any history of lack offenfluramine efficacy, or any history of valvulopathy at baseline with history offenfluramine use
Recent or concomitant use of serotonergic medications or monoamine oxidaseinhibitors
Presence of progressive central nervous system disease other than Dravet syndrome
Study Design
Connect with a study center
Alberta Children's Hospital
Calgary, Alberta AB T3B 6A8
CanadaSite Not Available
Stollery Children's Hospital
Edmonton, Alberta T6G 1C9
CanadaSite Not Available
Alberta Children's Hospital
Calgary 5913490, Alberta 5883102 AB T3B 6A8
CanadaSite Not Available
Stollery Children's Hospital
Edmonton 5946768, Alberta 5883102 T6G 1C9
CanadaSite Not Available
BC Children's Hospital
Vancouver, British Columbia V6H 3N1
CanadaSite Not Available
BC Children's Hospital
Vancouver 6173331, British Columbia 5909050 V6H 3N1
CanadaSite Not Available
Children's Hospital - VH, London Health Sciences Centre
London, Ontario N6A 4G5
CanadaSite Not Available
University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaSite Not Available
Children's Hospital - VH, London Health Sciences Centre
London 6058560, Ontario 6093943 N6A 4G5
CanadaSite Not Available
University of Toronto Division of Hematology Oncology/The Hospital for Sick Children
Toronto 6167865, Ontario 6093943 M5G 1X8
CanadaSite Not Available
Children's of Alabama / University of Alabama at Birmingham
Birmingham, Alabama 35226
United StatesSite Not Available
Children's of Alabama / University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35226
United StatesSite Not Available
University of California Los Angeles (UCLA)
Los Angeles, California 90095
United StatesSite Not Available
UCSD Rady's Children's Hosptial
San Diego, California 92123
United StatesSite Not Available
University of California Los Angeles (UCLA)
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
UCSD Rady's Children's Hosptial
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Northwest Florida Clinical Research Group
Gulf Breeze, Florida 32561
United StatesSite Not Available
Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United StatesSite Not Available
Miami Children's Hospital - Nicklaus Children's Hospital
Miami, Florida 33155
United StatesSite Not Available
Pediatric Neurology, P.A.
Winter Park, Florida 32789
United StatesSite Not Available
Northwest Florida Clinical Research Group
Gulf Breeze 4157634, Florida 4155751 32561
United StatesSite Not Available
Joe DiMaggio Children's Hospital
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Miami Children's Hospital - Nicklaus Children's Hospital
Miami 4164138, Florida 4155751 33155
United StatesSite Not Available
Pediatric Neurology, P.A.
Winter Park 4178560, Florida 4155751 32789
United StatesSite Not Available
Rare Disease Research Center Pediatrics, LLC
Atlanta, Georgia 30318
United StatesSite Not Available
Rare Disease Research Center Pediatrics, LLC
Atlanta 4180439, Georgia 4197000 30318
United StatesSite Not Available
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda, Maryland 20817
United StatesSite Not Available
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda 4348599, Maryland 4361885 20817
United StatesSite Not Available
Spectrum Health/ Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
Spectrum Health/ Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49503
United StatesSite Not Available
University of Missouri, Department of Child Health, Division of Neurology
Columbia, Missouri 65201
United StatesSite Not Available
University of Missouri, Department of Child Health, Division of Neurology
Columbia 4381982, Missouri 4398678 65201
United StatesSite Not Available
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey 07039
United StatesSite Not Available
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston 5100572, New Jersey 5101760 07039
United StatesSite Not Available
Northwell Health - Neuroscience Institute at Great Neck
New Hyde Park, New York 10075
United StatesSite Not Available
NYU Langone Comprehensive Epilepsy Center
New York, New York 10016
United StatesSite Not Available
New York Medical College
New York, New York 10019-1147
United StatesSite Not Available
NorthWell Health - Lennox Hill Hospital
New York, New York 11021
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Northwell Health - Neuroscience Institute at Great Neck
New Hyde Park 5128514, New York 5128638 10075
United StatesSite Not Available
NYU Langone Comprehensive Epilepsy Center
New York 5128581, New York 5128638 10016
United StatesSite Not Available
New York Medical College
New York 5128581, New York 5128638 10019-1147
United StatesSite Not Available
NorthWell Health - Lennox Hill Hospital
New York 5128581, New York 5128638 11021
United StatesSite Not Available
University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599-7025
United StatesSite Not Available
Duke University Hospital Center
Durham, North Carolina 27710
United StatesSite Not Available
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599-7025
United StatesSite Not Available
Duke University Hospital Center
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927 15224
United StatesSite Not Available
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesSite Not Available
The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
MultiCare Institute for Research & Innovation
Tacoma, Washington 98405
United StatesSite Not Available
Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available
MultiCare Institute for Research & Innovation
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

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