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Expanded Access Program for Patients With Migraine

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT03539393
Collaborator
(none)
23
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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:

  3. For HALO: Canada, Czech Republic, Spain or Finland

  4. 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 Design

Study Type:
Expanded Access
Official Title:
A Fremanezumab (TEV-48125) Expanded Access Program for Patients With Migraine

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Site 37096 Brugge Belgium
    2 Teva Investigational Site 37093 Brussels Belgium 1090
    3 Teva Investigational Site 37095 Hasselt Belgium 3500
    4 Teva Investigational Site 37094 Liege Belgium 4000
    5 Teva Investigational Site 11151 Newmarket Ontario Canada L3Y5G8
    6 Teva Investigational Site 11152 Sarnia Ontario Canada N7T 4X3
    7 Teva Investigational Site 11149 Calgary Canada
    8 Teva Investigational Site 54170 Brno Czechia 602 00
    9 Teva Investigational Site 54181 Ostrava-Moravska Czechia 702 00
    10 Teva Investigational Site 54171 Pardubice Czechia 530 02
    11 Teva Investigational Site 54167 Prague 6 Czechia 160 00
    12 Teva Investigational Site 54172 Prague Czechia
    13 Teva Investigational Site 54182 Praha 8 Czechia 186 00
    14 Teva Investigational Site 54173 Rychnov nad Kneznou Czechia 516 01
    15 Teva Investigational Site 30206 Firenze Italy 50134
    16 Teva Investigational Site 30211 Rome Italy 00128
    17 Teva Investigational Site 31247 Barcelona Spain 08029
    18 Teva Investigational Site 31240 Pamplona Spain 31008
    19 Teva Investigational Site 31249 Valencia Spain 46010
    20 Teva Investigational Site 31238 Zaragoza Spain 50009
    21 Teva Investigational Site 42059 Stockholm Sweden 112 81
    22 Teva Investigational Site 34239 Hull United Kingdom HU3 2JZ
    23 Teva Investigational Site 34237 Oxford United Kingdom OX3 9DU

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT03539393
    Other Study ID Numbers:
    • TV48125-CNS-80005
    First Posted:
    May 29, 2018
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Nov 11, 2021