NCT04289467RecruitingPhase 2
Treatment of Refractory Infantile Spasms With Fenfluramine
A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 21 Feb 2020
- Start date
- 16 Jun 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Children's Hospital of Orange County
- NCT number
- NCT04289467
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 16 Jun 2023 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
Other illness
- Significant preexisting cardiovascular disease
Other
- Exposure to any cannabinoid product within 14 days of screening
- Implantation of a vagal nerve simulator within 14 days of screening
- Initiation and maintenance of the ketogenic diet within 3 months of screening
Who the study is looking for
- Children ages 12 to 36 months, inclusive
- Clinical diagnosis of infantile spasms
- Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.
Age in the registry: 12 months to 36 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Health Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.