Fremanezumab Managed Access Program for Pediatric Patients

July 23, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

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

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).

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • Teva Investigational Site 37096
      • Brussels, Belgium, 1090
        • Teva Investigational Site 37093
      • Hasselt, Belgium, 3500
        • Teva Investigational Site 37095
      • Liege, Belgium, 4000
        • Teva Investigational Site 37094
  • Canada
      • Calgary, Canada
        • Teva Investigational Site 11149
    • Ontario
      • Newmarket, Ontario, Canada, L3Y5G8
        • Teva Investigational Site 11151
      • Sarnia, Ontario, Canada, N7T 4X3
        • Teva Investigational Site 11152
  • Czechia
      • Brno, Czechia, 602 00
        • Teva Investigational Site 54170
      • Ostrava-Moravska, Czechia, 702 00
        • Teva Investigational Site 54181
      • Pardubice, Czechia, 530 02
        • Teva Investigational Site 54171
      • Prague, Czechia
        • Teva Investigational Site 54172
      • Prague 6, Czechia, 160 00
        • Teva Investigational Site 54167
      • Praha 8, Czechia, 186 00
        • Teva Investigational Site 54182
      • Rychnov nad Kneznou, Czechia, 516 01
        • Teva Investigational Site 54173
  • Italy
      • Firenze, Italy, 50134
        • Teva Investigational Site 30206
      • Rome, Italy, 00128
        • Teva Investigational Site 30211
  • Spain
      • Barcelona, Spain, 08029
        • Teva Investigational Site 31247
      • Pamplona, Spain, 31008
        • Teva Investigational Site 31240
      • Valencia, Spain, 46010
        • Teva Investigational Site 31249
      • Zaragoza, Spain, 50009
        • Teva Investigational Site 31238
  • Sweden
      • Stockholm, Sweden, 112 81
        • Teva Investigational Site 42059
  • United Kingdom
      • Hull, United Kingdom, HU3 2JZ
        • Teva Investigational Site 34239
      • Oxford, United Kingdom, OX3 9DU
        • Teva Investigational Site 34237

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Child)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

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

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV48125-CNS-80005
  • TV48125-MH-80011 (Other Identifier: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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