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NCT06598449 · ClinicalTrials.gov registry record · Phase 4
Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age
A Phase 4 study of Dravet Syndrome (DS) and Children Under 2 Years, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 3
- Study locations
NCT06598449 is a Phase 4 study of Dravet Syndrome (DS) and Children Under 2 Years that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 12 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT06598449, a Phase 4 study of Dravet Syndrome (DS) and Children Under 2 Years, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 3
- Study locations
Study Summary
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 a treatment protocol to allow access to fenfluramine for children under 24 months of age.
Conditions Studied
Interventions
- DRUG fenfluramine
Study Locations (3)
California
- University of California San Francisco - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-10-22 |
| Est. Completion | 2027-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06598449
The ClinicalTrials.gov registry entry for NCT06598449 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dravet Syndrome (DS) appearing as the primary indexed condition, and to 1 intervention - of which fenfluramine is the first listed.
NCT06598449 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Colorado, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06598449 about?
NCT06598449 is a clinical study titled "Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age". 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 temp...
What is the current status of trial NCT06598449?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2024-10-22. Estimated completion is 2027-07.
What conditions does trial NCT06598449 study?
This clinical trial studies the following conditions: Dravet Syndrome (DS), Children Under 2 Years.
What interventions are being tested in trial NCT06598449?
The interventions under investigation include: fenfluramine (DRUG).
Who is sponsoring clinical trial NCT06598449?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06598449 being conducted?
This trial has 3 study locations across California, Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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