Trial Designs for Evaluating Migraine Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Active drug for acute migraine treatment: Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine
Placebo Oral Tablet: Inactive placebo pill (100 mg) looking like the active drug
Study 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.
Eligibility
Primary outcome measure(s)
- Headache intensity — Immediately before and 2 hours after each treatment administration
Headache intensity rated on a 11-point Numerical Rating Scale (("How intense is your headache right now?"; 0=no pain; 10=worst imaginable pain). - Adverse events — 2 hours after each treatment administration
Occurrence of adverse events in each treatment condition recorded by the presence of adverse events ascribed to the treatment, measured using structured prompting (fatigue/drowsiness, nausea/vomiting, altered taste, feeling of warmth, flushing, feeling of cold, heaviness, muscle pain, chest pain/pressure, tingling sensations, dizziness, shortness of breath, or any other adverse event/symptom). For each prompted symptom, participants respond "yes" or "no" and indicate whether they believe the symptom is related to the medication, the migraine attack, or another cause.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Dept. of Psychology and Behavioural Sciences | Aarhus C | Denmark | Not Yet Recruiting |
| Department of Neurology, Aarhus University Hospital | Aarhus N | Denmark | Recruiting |
More University of Aarhus trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06617832 on ClinicalTrials.gov ↗ ← All trials in Denmark