Status:
RECRUITING
Treatment of Refractory Infantile Spasms With Fenfluramine
Lead Sponsor:
Children's Hospital of Orange County
Conditions:
Infantile Spasm
Eligibility:
All Genders
12-36 years
Phase:
PHASE2
Brief Summary
This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, an...
Eligibility Criteria
Inclusion
- Children ages 12 to 36 months, inclusive
- Clinical diagnosis of infantile spasms
- Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.
Exclusion
- Significant preexisting cardiovascular disease
- Exposure to any cannabinoid product within 14 days of screening
- Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
- Implantation of a vagal nerve simulator within 14 days of screening
- Initiation and maintenance of the ketogenic diet within 3 months of screening
Key Trial Info
Start Date :
June 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04289467
Start Date
June 16 2023
End Date
December 31 2025
Last Update
February 7 2024
Active Locations (2)
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1
UCLA Health
Los Angeles, California, United States, 90095
2
Children's Hospital of Orange County
Orange, California, United States, 92868