ClinicalTrials.gg
AvailableNCT03539393Updated Jul 27, 2026

Fremanezumab Managed Access Program for Pediatric Patients

An expanded access record providing Fremanezumab in Migraine, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Available. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
6 Years to 17 Years
Sex
All
01

Study 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).

Read the detailed description

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

02

Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

Browse Migraine Disorders studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Additional criteria may apply, please contact your physician/investigator for more information.
05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • 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

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT03539393
Responsible party
Sponsor
First posted
May 29, 2018
Last update
Jul 27, 2026

Study contacts

Teva Medical Expert, MD
Contact
USMedInfo@tevapharm.com
1-888-483-8279
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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