NCT07071506

New Methods for Evaluating Preventive Migraine Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.

Detailed description

The existing paradigm for testing the effect of treatment is the double-blind randomized controlled trial (RCT) comparing an active drug to an inactive placebo. This comparison is done in order to control for contextual and psychological factors such as the patients' treatment expectations - a key factor in placebo responses. However, recent studies have indicated that some assumptions underlying the RCT may be incorrect and may lower the assay sensitivity and miscalculate the actual drug response. The so-called balanced placebo design (BPD) targets some of the shortcomings of the RCT by balancing the information given to the patients with the actual treatment administered. In this project, patients suffering from chronic migraine will receive a total of 4 injections over 8 months. Half of them are femanezumab, while the other half are placebo (an inactive injection). The injections (fremanezumab and placebo) look the same, and neither the patient nor the investigator know which injection will be administered. The order will be randomized. The injections are given with different information about what the patients are receiving. To avoid a carry-over effect, the patients will receive one injection every second month. The first month will be without treatment whereupon the patient will receive the first injection. During the first 28 days before and after each administration, patients rate outcome measures in an electronic pain/headache diary at home. In addition, they will also fill out questionnaires assessing their quality of life, psychological parameters and the headache burden.

Conditions

• Migraine
• Migraine With or Without Aura
• Headache Disorders
• Chronic Migraine, Headache

Interventions

Type	Name	Description
DRUG	Active drug for chronic migraine treatment.	Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously
DRUG	Placebo Subcutaneous injection	Inactive placebo (saline) injected subcutaneously in the same volume as the active drug

Timeline

• Start date: 2025-03-04
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-07-17
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Denmark