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NCT04289467 · ClinicalTrials.gov registry record · Phase 2
Treatment of Refractory Infantile Spasms With Fenfluramine
A Phase 2 study, sponsored by Children's Hospital of Orange County.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04289467 is a Phase 2 study that is actively recruiting participants, run by Children's Hospital of Orange County. The registered enrollment target is 10 participants.
The verdict
NCT04289467, a Phase 2 study, is actively recruiting participants, sponsored by Children's Hospital of Orange County.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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, 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.
Interventions
- DRUG Fenfluramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04289467
The ClinicalTrials.gov registry entry for NCT04289467 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Orange County, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fenfluramine is the first listed.
NCT04289467 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04289467 about?
NCT04289467 is a clinical study titled "Treatment of Refractory Infantile Spasms With Fenfluramine". 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 ...
What is the current status of trial NCT04289467?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2023-06-16. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT04289467?
The interventions under investigation include: Fenfluramine (DRUG).
Who is sponsoring clinical trial NCT04289467?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
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