Infantile Spasm Clinical Trial
Official title:
A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms
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 | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 36 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Health | Los Angeles | California |
United States | Children's Hospital of Orange County | Orange | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Orange County |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electroclinical response (Efficacy) | Number of participants with resolution of epileptic spasms and hypsarrhythmia (if present at baseline) after 21 days of treatment, as determined by overnight video-electroencephalography (EEG) evaluation and caregiver seizure diary. | 12 months | |
Secondary | Computational electroencephalography response (Efficacy) | Median and range of response quantified using the probability-weighted response index (PWRI), a novel computational electroencephalography measure of hypsarrhythmia burden. | 12 months | |
Secondary | Incidence of treatment emergent adverse events (Safety and tolerability) | Detailed accounting of all treatment-emergent adverse events, including number of participants with clinically-significant valvulopathy and/or pulmonary hypertension, as determined by echocardiography. | 12 months |
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