Treatment of Refractory Infantile Spasms With Fenfluramine
ConditionInfantile Spasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-36
SponsorChildren's Hospital of Orange County
About this trial
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 criteria
Qualifiers
Children ages 12 to 36 months, inclusive
Clinical diagnosis of infantile spasms
Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fenfluramine
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov