Treatment of Refractory Infantile Spasms With Fenfluramine

Launched by CHILDREN'S HOSPITAL OF ORANGE COUNTY · Feb 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fenfluramine to see if it can help treat infants and toddlers who have a condition known as refractory infantile spasms, which is a type of severe epilepsy. The trial is open to children aged between 12 and 36 months who are still experiencing these spasms despite having already tried treatments like vigabatrin and ACTH. If your child qualifies, they will undergo some tests, including a video EEG, which helps monitor brain activity, and then receive fenfluramine for 21 days. After this period, another EEG will be done to see how well the medication worked.

If the treatment shows positive results, there’s an opportunity for your child to continue taking fenfluramine for up to six months. It’s important to note that children with serious heart problems, recent exposure to certain treatments, or those who have started specific diets or devices for seizures may not be eligible for this study. If you're considering participation, this trial could offer a potential new option for managing your child’s condition.

Gender

ALL

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