NCT03539393

Fremanezumab Compassionate Use Program for Pediatric Patients

Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: —

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).

Detailed description

Patients must have successfully completed the clinical trial according to the 30084 protocol, without any major protocol violations or tolerability issues, or who are anticipated to complete this trial within the next 2months, and whose Requesting/Treating Physician is requesting continued supply of the investigational medicinal product (IMP) known as TEV-48125 (fremanezumab) on behalf of the patient.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab	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.

Timeline

• First posted: 2018-05-29
• Last updated: 2025-07-23