Clinical Trials Logo
  1. Home
  2. Drug Resistant Epilepsy
  3. NCT04457687
  4. Details
NCT04457687 Clinical Trial

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

Drug Resistant Epilepsy Clinical Trial

Official title:
Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT04457687
Other study ID # E2023-A001-405
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date May 2024
Source Eisai Inc.
Contact Eisai Medical Information
Phone +1-888-274-2378
Email esi_medinfo@eisai.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 2 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lorcaserin
Lorcaserin 10 milligram (mg) tablets orally.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Inc.
See also
  Status Clinical Trial Phase
Completed NCT04378075 - A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy Phase 2/Phase 3
Recruiting NCT05928598 - Goals for Epilepsy Clinic Visits Trial N/A
Recruiting NCT05539287 - Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy Phase 2
Not yet recruiting NCT04601974 - Lentiviral Gene Therapy for Epilepsy Phase 1/Phase 2
Completed NCT02982824 - Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy N/A
Recruiting NCT05485558 - the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy Phase 2
Not yet recruiting NCT04553354 - Cortical Resections in Drug Resistant Epilepsy
Recruiting NCT04999046 - NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy N/A
Recruiting NCT04714996 - Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy Phase 2
Recruiting NCT04839601 - RNS System RESPONSE Study N/A
Recruiting NCT06059157 - Epileptogenic Network Visualisation With Advanced MRI N/A
Recruiting NCT05947656 - Evaluation of the NaviFUS System in Drug Resistant Epilepsy N/A
Recruiting NCT05393518 - Electroclinical Correlation of Anxiety N/A
Not yet recruiting NCT05555537 - MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy
Completed NCT03419000 - Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY N/A
Enrolling by invitation NCT06341075 - Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy N/A
Not yet recruiting NCT05527093 - Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy N/A
Recruiting NCT05697614 - The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children Phase 4
Recruiting NCT06309251 - Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Recruiting NCT06432907 - StereoEEG Motor Neuronal Potentials Decoding N/A