Back to resultsExtended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
Primary Purpose
Epilepsies, Myoclonic, Drug Resistant Epilepsy
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Lorcaserin
Sponsored by
About this trial
This is an expanded access trial for Epilepsies, Myoclonic focused on measuring Extended Access Program, Expanded Access Program, Dravet Syndrome, Refractory Epilepsies, Lorcaserin
Eligibility Criteria
Inclusion Criteria:
- 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)
- Male or female, age at least 2 years at the time of informed consent
- 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
- Has a clinical benefit from lorcaserin in the opinion of the treating physician
Exclusion Criteria:
None
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457687
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Myoclonic, Drug Resistant Epilepsy
Keywords
Extended Access Program, Expanded Access Program, Dravet Syndrome, Refractory Epilepsies, Lorcaserin
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Other Intervention Name(s)
E2023
Intervention Description
Lorcaserin 10 milligram (mg) tablets orally.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Eligibility Criteria
Inclusion Criteria:
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)
Male or female, age at least 2 years at the time of informed consent
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
Has a clinical benefit from lorcaserin in the opinion of the treating physician
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eisai Medical Information
Phone
+1-888-274-2378
Email
esi_medinfo@eisai.com
12. IPD Sharing Statement
Learn more about this trial
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
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