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Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 12 to 5 Study sites: 3 to 1 · Eligibility criteria shortened, about 43 words · Collaborators shortened, about 2 wordsv4 Show 3 more changesShow less
    • Study sites: 3 to 1
    • Eligibility criteria shortened, about 43 words
    • Collaborators shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2024 to Oct 22, 2024 · Site details revised at 3 of 3 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2024 to Oct 22, 2024
    • Site details revised at 3 of 3 sites
  3. Start date: Sep 2024 to Oct 2024 Study title shortened, about 1 wordv2 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Dravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav1.1, a protein necessary for sodium channels. Children with Dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. This creates some limitations in medication choices for this patient population. Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older. Randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. Additionally, 16% of children treated with fenfluramine were seizure free. Fenfluramine is likely to be as effective in children under the age of 2 years. The current study has proposed an intermediate size patient population expanded access protocol to allow access to fenfluramine for children under 24 months of age.
Trial Details
NCT Number NCT06598449
Lead Sponsor University of Colorado, Denver
Conditions Dravet Syndrome (DS), Children Under 2 Years
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov