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NCT04289467
Treatment of Refractory Infantile Spasms With Fenfluramine
Phase 2 trial testing Fenfluramine in Infantile Spasm in 10 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Children's Hospital of Orange County |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 16 June 2023 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Fenfluramine (FENFLURAMINE) — full drug profile →
Conditions studied
- Infantile Spasm — all drugs for Infantile Spasm →
Sponsor
Children's Hospital of Orange County
Who can join
Adults 12 Months to 36 Months, any sex, with Infantile Spasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fenfluramine: A Review of Pharmacology, Clinical Efficacy, and Safety in Epilepsy.
Samanta D. · · 2022 · cited 25× · PMID 36010049 · DOI 10.3390/children9081159 -
Improving Therapy of Pharmacoresistant Epilepsies: The Role of Fenfluramine.
Dini G, Tulli E, Dell'Isola GB, Mencaroni E, et al · · 2022 · cited 11× · PMID 35668937 · DOI 10.3389/fphar.2022.832929 -
Reintroducing Fenfluramine as a Treatment for Seizures: Current Knowledge, Recommendations and Gaps in Understanding.
Dini G, Di Cara G, Ferrara P, Striano P, et al · · 2023 · cited 8× · PMID 37790801 · DOI 10.2147/ndt.s417676
Verify or expand the search:
- PubMed search for NCT04289467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fenfluramine
Trials testing the same drug.
- NCT05560282 — Fenfluramine for Adult Dravet Patients · Phase 3 · unknown
- NCT05232630 — Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Explori · Phase 4 · unknown
- NCT05026398 — Fenfluramine and Cognition · Phase 4 · completed
- NCT00000313 — Predictive Values of Serotonergic Alterations for Outcome - 2 · Phase 1 · terminated
- NCT04437004 — Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) · available
Other Children's Hospital of Orange County trials
Trials by the same sponsor.
- NCT07414199 — The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department · Phase 4 · not yet recruiting
- NCT07435610 — Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction · NA · recruiting
- NCT07361536 — Cardiac Structure and Function in MPS · recruiting
- NCT06772662 — One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement · NA · recruiting
- NCT06274008 — Exparel vs. ACB With Bupivacaine for ACL Reconstruction · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04289467 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Orange County
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04289467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing