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Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies

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ClinicalTrials.gov Identifier: NCT04457687
Expanded Access Status : Available
First Posted : July 7, 2020
Last Update Posted : June 6, 2022
Information provided by (Responsible Party):
Eisai Inc.

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
Epilepsies, Myoclonic Drug Resistant Epilepsy Drug: Lorcaserin

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies

Intervention Details:
  • Drug: Lorcaserin
    Lorcaserin 10 milligram (mg) tablets orally.
    Other Name: E2023

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457687

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Contact: Eisai Medical Information +1-888-274-2378 esi_medinfo@eisai.com

Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT04457687    
Other Study ID Numbers: E2023-A001-405
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: May 2022
Keywords provided by Eisai Inc.:
Extended Access Program
Expanded Access Program
Dravet Syndrome
Refractory Epilepsies
Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Epilepsies, Myoclonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes