Expanded Access Program for Patients With Migraine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03539393|
Expanded Access Status : Available
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
|Condition or disease||Intervention/treatment|
|Migraine Cluster Headache||Drug: Fremanezumab|
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.
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|Official Title:||A Fremanezumab (TEV-48125) Expanded Access Program for Patients With Migraine|
- Drug: Fremanezumab
quarterly 675 mg dose (3 subcutaneous [SC] injections of 225 mg each).
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
|Contact: Teva Medical Expert, MD||1-888-483-8279||USMedInfo@tevapharm.com|