Expanded Access Program for Patients With Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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Fremanezumab is indicated for patient suffering from Episodic or Chronic Migraine. Patients interested in received expanded access to Fremanezumab must meet the following conditions: Have participated in, and successfully completed, one of the two clinical studies TV48125-CNS-30051 (HALO) or TV48125-CNS-30068 (FOCUS) Participated from one of the following countries: For HALO: Canada, Czech Republic, Spain or Finland 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.

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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Fremanezumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fremanezumab|quarterly 675 mg dose (3 subcutaneous [SC] injections of 225 mg each).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |