Treatment of Refractory Infantile Spasms With Fenfluramine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fenfluramine.
- Who it may be relevant to
- Registry conditions: Infantile Spasm. Basic parameters: 12 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms
Overview
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.
Interventions
- Drug Fenfluramine
Open-label
Primary outcome measures
- Electroclinical response (Efficacy) [Time frame: 12 months]
Secondary outcome measures (2)
- Computational electroencephalography response (Efficacy) [Time frame: 12 months]
- Incidence of treatment emergent adverse events (Safety and tolerability) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- UCLA Health — Los Angeles
- Children's Hospital of Orange County — Orange
Identifiers
NCT: NCT04289467 · ZX008-IS