RECRUITING

Treatment of Refractory Infantile Spasms With Fenfluramine

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms

Quick Facts

Study Start:2023-06-16
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04289467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 36 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children ages 12 to 36 months, inclusive
  2. * Clinical diagnosis of infantile spasms
  3. * Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.
  1. * Significant preexisting cardiovascular disease
  2. * Exposure to any cannabinoid product within 14 days of screening
  3. * Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
  4. * Implantation of a vagal nerve simulator within 14 days of screening
  5. * Initiation and maintenance of the ketogenic diet within 3 months of screening

Contacts and Locations

Study Contact

Angelyque Lorenzana, MA
CONTACT
714-509-8972
alorenzana@choc.org
Virginia Allhusen, PhD
CONTACT
vallhusen@choc.org

Principal Investigator

Daniel Shrey, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Orange County

Study Locations (Sites)

UCLA Health
Los Angeles, California, 90095
United States
Children's Hospital of Orange County
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Orange County

  • Daniel Shrey, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Orange County

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-16
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-06-16
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Infantile Spasm