Treatment of Refractory Infantile Spasms With Fenfluramine

Conditions

• Infantile Spasm

Eligibility Criteria

Sex

ALL

Age

12 Months - 36 Months

Healthy Volunteers

Not accepted

Interventions

• Fenfluramine — DRUG
  Open-label

Study Details

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.

Key Dates

Start date

Jun 16, 2023

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Fenfluramine treatment
  Open label treatment with fenfluramine. Dosage will be titrated to 0.8 mg/kg/day, for an initial duration of 21 days. Patients with favorable response will have an option to continue treatment for up to 6 months.

Primary Outcome Measure

Electroclinical response (Efficacy) [ Time Frame: 12 months ]

Central Contacts

• Kellie Bacon, MPH
  714-509-8972
  [email protected]
• Virginia Allhusen, PhD
  [email protected]

Locations (2)

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