Clinical trial NCT04457687: Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
Official title: Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Epilepsies, Myoclonic
Drug Resistant Epilepsy
Keywords: Extended Access Program
Expanded Access Program
Dravet Syndrome
Refractory Epilepsies
Lorcaserin
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-07
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.


Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the treating physician)
2. Male or female, age at least 2 years at the time of informed consent
3. Currently treated with lorcaserin, that the treatment is for Dravet syndrome or other refractory epilepsies, and the treatment was initiated before 13 Feb 2020; or has completed Study E2023-A001-304
4. Has a clinical benefit from lorcaserin in the opinion of the treating physician

Exclusion Criteria:

None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: David Geffen School of Medicine, UCLA Mattel Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Avon
country: United States
facility: Pena
state: Connecticut
city: Greenwich
country: United States
facility: (Resor)
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clinical Neurosciences of Tampa Bay
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital - Nicklaus Children's Hospital Miami
state: Florida
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center - Bethesda
state: Maryland
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Hackensack
country: United States
facility: Northeastern Regional Epilepsy Group (Hackensack)
state: New Jersey
city: Hawthorne
country: United States
facility: New York Medical College
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: Mt. Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Sidney Kimmel Medical College at Thomas Jefferson University
state: Pennsylvania
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: Calgary
country: Canada
facility: Alberta Children's Hospita
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
Study officials:
References: