Expanded Access Program for Patients With Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03539393
• Other study ID #: TV48125-CNS-80005
• Status: No longer available

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Fremanezumab
quarterly 675 mg dose (3 subcutaneous [SC] injections of 225 mg each).

Locations

Country	Name	City	State
Belgium	Teva Investigational Site 37096	Brugge
Belgium	Teva Investigational Site 37093	Brussels
Belgium	Teva Investigational Site 37095	Hasselt
Belgium	Teva Investigational Site 37094	Liege
Canada	Teva Investigational Site 11149	Calgary
Canada	Teva Investigational Site 11151	Newmarket	Ontario
Canada	Teva Investigational Site 11152	Sarnia	Ontario
Czechia	Teva Investigational Site 54170	Brno
Czechia	Teva Investigational Site 54181	Ostrava-Moravska
Czechia	Teva Investigational Site 54171	Pardubice
Czechia	Teva Investigational Site 54172	Prague
Czechia	Teva Investigational Site 54167	Prague 6
Czechia	Teva Investigational Site 54182	Praha 8
Czechia	Teva Investigational Site 54173	Rychnov nad Kneznou
Italy	Teva Investigational Site 30206	Firenze
Italy	Teva Investigational Site 30211	Rome
Spain	Teva Investigational Site 31247	Barcelona
Spain	Teva Investigational Site 31240	Pamplona
Spain	Teva Investigational Site 31249	Valencia
Spain	Teva Investigational Site 31238	Zaragoza
Sweden	Teva Investigational Site 42059	Stockholm
United Kingdom	Teva Investigational Site 34239	Hull
United Kingdom	Teva Investigational Site 34237	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

Belgium,  Canada,  Czechia,  Italy,  Spain,  Sweden,  United Kingdom,