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Fremanezumab Managed Access Program for Pediatric Patients

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03539393
Enrollment
Unknown
Registered
2018-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

This is a Managed Access Program (MAP) based on a licensed physician's unsolicited request on a compassionate basis. Specifically, this MAP 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

Eligibility for managed access of TV-48125 (fremanezumab) is currently only open to patients have successfully completed the TV48125-CNS-30084 study.

Interventions

DRUGFremanezumab

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.

Sponsors

Teva Branded Pharmaceutical Products R&D LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years

Inclusion criteria

* 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.

Exclusion criteria

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

Contacts

CONTACTTeva Medical Expert, MD
USMedInfo@tevapharm.com1-888-483-8279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026