Expanded Access Program for Patients With Migraine

November 10, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Fremanezumab (TEV-48125) Expanded Access Program for Patients With Migraine

This expanded access program is designed to make fremanezumab available to patients with EM or CM who have successfully completed (per protocol) Teva-sponsored Study TV48125-CNS-30051 or TV48125-CNS-30068 ("prior studies") until fremanezumab becomes commercially available in their country.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Fremanezumab is indicated for patient suffering from Episodic or Chronic Migraine.

Patients interested in received expanded access to Fremanezumab must meet the following conditions:

  1. Have participated in, and successfully completed, one of the two clinical studies TV48125-CNS-30051 (HALO) or TV48125-CNS-30068 (FOCUS)

  2. Participated from one of the following countries:

    1. For HALO: Canada, Czech Republic, Spain or Finland
    2. For FOCUS: Czech Republic, Spain, Finland, Germany, Sweden, Denmark, Netherlands, Italy, France or Belgium Eligible patients should contact their study physician to request expanded access.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

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 (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient must have completed Teva-sponsored Study TV48125-CNS-30051 or TV48125-CNS-30068 as defined in the study protocol and without major protocol violations.
  • The patient is unable to obtain fremanezumab under another Investigational New Drug or through a clinical study.
  • In the opinion and clinical judgement of the treating physician, the risk/benefit for the patient supports continuing treatment with fremanezumab.
  • The treating physician determined that there is no other comparable or satisfactory therapy available to treat the patient.
  • Women may be included only if they have a negative serum beta-human chorionic gonadotropin test at enrollment, are sterile, or postmenopausal.
  • Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of their participation in the program and for 7.5 months after discontinuation of fremanezumab.
  • Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of their participation in the program and for 7.5 months after discontinuation of fremanezumab.
  • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient had any finding on their last available test that, in the judgment of the treating physician, is a clinically significant abnormality, including hematology values, serum chemistry, coagulation tests, or urinalysis (abnormal tests may be repeated for confirmation).
  • The patient is a pregnant or lactating/nursing female or plans to become pregnant during the program or for 7.5 months after discontinuing treatment.
  • The patient had any finding in their last available 12-lead electrocardiogram considered clinically significant in the judgment of the treating physician.

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, Inc.

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)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV48125-CNS-80005

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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