Treatment of Refractory Infantile Spasms With Fenfluramine
Recruiting
Phase 2
Interventional Study
Infantile Spasm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 Months – 36 Months
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Children's Hospital of Orange County · Other
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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, rece…
Trial Locations
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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 with…
Contacts