A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms

Who is this study for? Patients with Infantile Spasms
What treatments are being studied? Fenfluramine
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: f
View:

• Children ages 12 to 36 months, inclusive

• Clinical diagnosis of infantile spasms

• Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.

Locations
United States
California
UCLA Health
NOT_YET_RECRUITING
Los Angeles
Children's Hospital of Orange County
RECRUITING
Orange
Contact Information
Primary
Angelyque Lorenzana, MA
alorenzana@choc.org
714-509-8972
Backup
Virginia Allhusen, PhD
vallhusen@choc.org
Time Frame
Start Date: 2023-06-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10
Treatments
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.
Authors
Shaun Hussain
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Orange County

This content was sourced from clinicaltrials.gov