Last updated on December 2019

A Study to Test if Fremanezumab Reduces Headache in Patients With Posttraumatic Headache (PTH)


Brief description of study

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult patients aged 18 to 70 years, inclusive, for the prevention of PTH. Patients will provide written informed consent and during study visits they will use an electronic diary application daily, to report their headache status and other health information. Efficacy and immunogenicity status will be captured periodically and at study termination. The safety will be evaluated through adverse event report, concomitant medication inquiries, ECGs, clinical laboratory tests and physical examination. Additional evaluations will include pharmacokinetic, biomarker, and pharmacogenomics. All patients will continue the DB period in an open label period during 12 weeks with a monthly dose of 675 mg sc.

Clinical Study Identifier: NCT03347188

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