Trial Designs for Evaluating Migraine Treatment

NCT06617832 | Recruiting

• 1 other identifier: UAarhus_Acute migraine
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Migraine With Aura; Migraine Without Aura; Headache, Migraine

Keywords

Headache; Episodic migraine; Randomized controlled trial; Balanced placebo design; Treatment effects; Adverse events

Outcome Measures

Primary Outcomes (2)

• Headache intensity

  Headache intensity rated on a 11-point Numerical Rating Scale (("How intense is your headache right now?"; 0=no pain; 10=worst imaginable pain).

  Immediately before and 2 hours after each treatment administration

• Adverse events

  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.

  2 hours after each treatment administration

Secondary Outcomes (10)

• Positive and negative affect (PANAS)

  Before and 2 hours after each treatment administration

• Functional disability scale

  2 hours after each treatment administration

• Rescue medication

  2 hours after each treatment administration

• Pain Freedom

  2 hours after each treatment administration

• Absence of the most bothersome migraine-associated symptom

  2 hours after each treatment administration

Other Outcomes (2)

• Expectations

  Immediately after each treatment administration

• Desire for pain relief

  Immediately after each treatment administration

Study Arms (2)

Active group

ACTIVE COMPARATOR

Active drug

Drug: Active drug for acute migraine treatment

Placebo group

PLACEBO COMPARATOR

Inactive placebo

Drug: Placebo Oral Tablet

Interventions

Placebo Oral Tablet DRUG

Inactive placebo pill (100 mg) looking like the active drug

Placebo group

Active drug for acute migraine treatment DRUG

Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine

Active group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-65 years)
• ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
• Known episodic migraine (≥ 1 and \< 15 headache days with features of migraine on at least 2-8 days per month for \> 3 months) with and without aura and diagnosed before age 50
• Previous or active use of triptans as acute treatment for migraine
• Ability to speak and read Danish

You may not qualify if:

• Chronic migraine or history of chronic migraine in the last 12 months
• Other concomitant primary headache types except for infrequent tension-type headache
• Secondary headache disorders including medication overuse headache
• Severe psychiatric, vascular or liver diseases
• Opioid or barbiturate use in the month preceding screening
• Contraindications or inability to tolerate triptans
• Current substance use disorder
• Implanted metallic or electronic device in the head
• Cardiac pacemaker or implanted or wearable defibrillator
• Use of illegal psychotropic drugs less than a week before participation in the study; regarding cannabis: less than four weeks before participation in the study
• Current pregnancy or planned pregnancy (confirmed by pregnancy test and by use of safe contraception as defined by the Danish Medicines Agency) and lactation

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Dept. of Psychology and Behavioural Sciences

Aarhus C, 8000, Denmark

NOT YET RECRUITING

Department of Neurology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura; Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sigrid Juhl Lunde, MSc, PhD

CONTACT

4587165956; lunde@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled cross-over design where patients receive 1) sumatriptan or 2) placebo and are told that they receive a) sumatriptan or placebo, b) sumatriptan, or c) placebo

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available following publication of the primary results, with no predefined end date.
• Access Criteria: Data will be shared with researchers upon reasonable request, subject to approval by the study investigators. Data will be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and in accordance with applicable data protection regulations. A data sharing agreement may be required.

Locations

DK (2)