Evaluating New Ways to Prevent Chronic Migraine with Fremanezumab and Placebo Injections

What this Trial Is About

Researchers are evaluating how drug and placebo responses interact in treating chronic migraine and how adverse events vary depending on the treatment information given to patients. This study uses a balanced placebo design to address limitations of traditional double-blind randomized controlled trials. Patients with chronic migraine will receive four injections over eight months in a randomized order to better understand treatment effects and the role of patient expectations. Participants will receive four injections spaced two months apart after a one-month baseline period without treatment. Half of the injections are fremanezumab, an active drug, and the other half are inactive placebo injections, all appearing identical. Neither patients nor investigators know which injection is given at each visit, and information about the treatment will also be varied to assess its impact. Patients complete electronic pain and headache diaries daily for 28 days before and after each injection and fill out questionnaires on quality of life, psychological factors, and headache burden. During the trial, researchers will monitor headache intensity and frequency daily, as well as adverse events at multiple time points after each injection. Additional measures include migraine days, acute treatment use, mood and anxiety scales, and quality of life assessments. Patient adherence and blinding will be evaluated throughout. The study is expected to last eight months, with assessments and questionnaires completed regularly to track treatment effects and safety.

New Methods for Evaluating Preventive Migraine Treatment