NCT06617832

Trial Designs for Evaluating Migraine Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (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, advanced balanced placebo design, patients with episodic migraine will receive six treatment conditions in a randomized order.

Detailed description

The existing paradigm for testing the effect of treatments 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 study results 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 the shortcomings of the RCT by balancing the information given to the patients (correct or false) with the actual treatment administered (active treatment or placebo). In this project, the aim is to examine whether the active drug response and the placebo response interact in acute migraine treatment. Patients suffering from episodic migraine will go through six treatment conditions in randomized order. They will receive acute migraine treatment (a sumatriptan pill) or inactive treatment (a placebo pill) in the event of a developing migraine attack. Using a clinical within-subjects design, the patients receive 1) sumatriptan or 2) placebo and are told that they receive a) sumatriptan or placebo, b) sumatriptan, or c) placebo. All treatments and accompanying treatment descriptions will be administered at home.

Conditions

• Migraine With Aura
• Migraine Without Aura
• Headache, Migraine

Interventions

Type	Name	Description
DRUG	Active drug for acute migraine treatment	Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine
DRUG	Placebo Oral Tablet	Inactive placebo pill (100 mg) looking like the active drug

Timeline

• Start date: 2024-11-13
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-10-01
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Denmark