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Treatment of Refractory Infantile Spasms With Fenfluramine

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Site contacts updated at 1 of 2 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2023 to Jun 16, 2023
    • Site details revised at 2 of 2 sites
    v4
  3. Study sites: 1 to 2v3
  4. Lead sponsor: University of California, Los Angeles to Children's Hospital of Orange Countyv2 Show 5 more changesShow less
    • Primary completion date: Dec 31, 2021 to Dec 31, 2024
    • Start date: Apr 1, 2020 to Sep 1, 2023
    • Study completion date: Dec 31, 2021 to Dec 31, 2025
    • Eligibility criteria revised
    • Study site revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo repeat video-EEG to determine effectiveness. Patients with favorable response will have the opportunity to continue treatment for up to 6 months.
Trial Details
NCT Number NCT04289467
Lead Sponsor Children's Hospital of Orange County
Conditions
(from sponsor)		 Infantile Spasm
Related terms Spasms, Infantile
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov