Treatment of Refractory Infantile Spasms With Fenfluramine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infantile Spasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fenfluramine

Intervention Type DRUG

Open-label

Interventions

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Fenfluramine

Open-label

Intervention Type DRUG

Other Intervention Names

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Fenfluramine Hydrochloride

Eligibility Criteria

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Inclusion Criteria

* Children ages 12 to 36 months, inclusive
* Clinical diagnosis of infantile spasms
* Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.

Exclusion Criteria

* Significant preexisting cardiovascular disease
* Exposure to any cannabinoid product within 14 days of screening
* Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
* Implantation of a vagal nerve simulator within 14 days of screening
* Initiation and maintenance of the ketogenic diet within 3 months of screening

Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No