A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Episodic Cluster Headache
ENFORCE STUDY: A study for patients with episodic cluster headaches using study drug TEV-48125 (Fremanezumab)
Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.
Enrolling: Male and Female Patients
Study Length: 16 Weeks
Clinic Visits: 5
IRB Number: AAAR1517
U.S. Govt. ID: NCT02945046
Contact: Marianna Yugrakh, MD: (212) 305-6876 / ms3006@cumc.columbia.edu
Additional Study Information: The ENFORCE Teva Cluster Headache clinical trial is looking for people who have been diagnosed with episodic cluster headaches to participate. People who volunteer and qualify may have the opportunity to try an investigational study drug for cluster headaches. If you're 18 to 70 years old and have experienced cluster headaches for 12 months or more, you may be able to enroll. In this clinical research study, you may receive investigational study drug or may receive a placebo based on treatment group randomization. You'll also receive study-related care from the principal investigator and possible compensation for travel. The study doctor will also check other requirements to see if you're eligible to participate. This trial runs for 16 weeks and requires 5 visits to our clinic at the Columbia University Medical Center. Typical visit procedures include blood tests, physical exam, medical questionnaires, and an EKG.
This study is closed
Investigator
Marianna Shnayderman Yugrakh, MD
Do You Qualify?
Are you 18 to 70 years of age? Yes No
Have you been getting cluster headaches for at least 12 months? Yes No
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You may be eligible for this study

Place Holder




For more information, please contact:
Marianna Yugrakh, MD
ms3006@cumc.columbia.edu
(212) 305-6876