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Expanded Access Program for Patients With Migraine

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ClinicalTrials.gov Identifier: NCT03539393
Expanded Access Status : Available
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

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
Migraine Cluster Headache Drug: Fremanezumab

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
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Fremanezumab (TEV-48125) Expanded Access Program for Patients With Migraine

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539393


Contacts
Contact: Teva Medical Expert, MD 1-888-483-8279 USMedInfo@tevapharm.com

Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03539393     History of Changes
Other Study ID Numbers: TV48125-CNS-80005
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Migraine Disorders
Headache
Cluster Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias