Fremanezumab Compassionate Use Program for Pediatric Patients

NCT03539393 | Unknown

• 2 other identifiers: TV48125-CNS-80005TV48125-MH-80011
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Compassionate Use Program (CUP) based on a licensed physician's unsolicited request. Specifically, this CUP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).

Conditions

Migraine

Interventions

Fremanezumab DRUG

For patients who enter this program, the monthly dose of fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the patient's weight every 3 months.

Also known as: TEV-48125

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures
• In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.

You may not qualify if:

• Additional criteria may apply, please contact your physician/investigator for more information.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Teva Medical Expert, MD

CONTACT

1-888-483-8279; USMedInfo@tevapharm.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Last Updated: July 23, 2025

Record last verified: 2025-07