Infantile Spasm study: Fenfluramine
Official title Treatment of Refractory Infantile Spasms With Fenfluramine
ClinicalTrials.gov ID: NCT04289467
What this study is testing
What is Fenfluramine?
Fenfluramine is an investigational medicine, being studied as a potential treatment for infantile spasm.
Also referred to as Fenfluramine Hydrochloride.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether fenfluramine works well. It also checks how safe the medicine is and what side effects it causes.
- Who it's for
- You may be able to join if your baby has spasms that did not get better with other treatments.
- What's involved
- You would give your baby fenfluramine for 21 days. The team will record brain activity before and after this time.
- Time commitment
- The main test lasts 21 days, but some babies may stay on the medicine for up to 6 months.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 36
You may be able to join if
- Children ages 12 to 36 months, inclusive
- Clinical diagnosis of infantile spasms
- Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 36 months. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orange, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.