Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
Sponsor
Eisai Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT04457687
Collaborator
(none)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
Official Title:
Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eisai Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT04457687
Other Study ID Numbers:
- E2023-A001-405
First Posted:
Jul 7, 2020
Last Update Posted:
Jun 6, 2022
Last Verified:
May 1, 2022
Keywords provided by Eisai Inc.
Additional relevant MeSH terms: