Clinical trial
Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies
Name
E2023-A001-405
Description
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
Trial arms
Treatment
Lorcaserin
Lorcaserin 10 milligram (mg) tablets orally.
Other names:
E2023
Size
-1
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
Protocol
{'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1, 'expandedAccessTypes': {'intermediate': True}}
Updated at
2023-06-09
1 organization
1 product
3 indications
Product
LorcaserinIndication
EpilepsyIndication
MyoclonicIndication
Drug-Resistant EpilepsyOrganization
Eisai