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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
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Lorcaserin

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

Contacts and Locations
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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


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

Sponsors and Collaborators
Eisai Inc.
More Information
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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
Lorcaserin
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Epilepsies, Myoclonic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes