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RECRUITINGINTERVENTIONAL

Trial Designs for Evaluating Migraine Treatment

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study aims to estimate treatment effects in randomized controlled trials (RCT) and a balanced placebo design (BPD) to specify how contextual and psychological factors interact in acute migraine treatment and influence adverse event occurrence. Using a clinical within-subjects design, patients with episodic migraine will receive six treatment conditions in a randomized order.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults (18-65 years) 2. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria 3. 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 4. Previous or active use of triptans as acute treatment for migraine 5. Ability to speak and read Danish Who Should NOT Join This Trial: 1. Chronic migraine or history of chronic migraine in the last 12 months 2. Other concomitant primary headache types except for infrequent tension-type headache 3. Secondary headache disorders including medication overuse headache 4. Severe psychiatric, vascular or liver diseases 5. Opioid or barbiturate use in the month preceding screening 6. Current use of preventive migraine treatment (i.e., onabotulinum toxin A, and/or Calcitonin gene-related peptide (CGRP) monoclonal antibodies) (however, stable medical treatment with other migraine prophylactic agents is permitted, e.g. antidepressant, calcium channel blockers, beta blockers and antiepileptic drugs, 4 weeks prior to baseline until the completion of participation in the study) 7. Contraindications or inability to tolerate triptans 8. Current substance use disorder 9. Implanted metallic or electronic device in the head 10. Cardiac pacemaker or implanted or wearable defibrillator 11. 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 12. Current pregnancy or planned pregnancy (confirmed by pregnancy test and by use of safe contraception as defined by the Danish Medicines Agency) and lactation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adults (18-65 years) 2. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria 3. 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 4. Previous or active use of triptans as acute treatment for migraine 5. Ability to speak and read Danish Exclusion Criteria: 1. Chronic migraine or history of chronic migraine in the last 12 months 2. Other concomitant primary headache types except for infrequent tension-type headache 3. Secondary headache disorders including medication overuse headache 4. Severe psychiatric, vascular or liver diseases 5. Opioid or barbiturate use in the month preceding screening 6. Current use of preventive migraine treatment (i.e., onabotulinum toxin A, and/or Calcitonin gene-related peptide (CGRP) monoclonal antibodies) (however, stable medical treatment with other migraine prophylactic agents is permitted, e.g. antidepressant, calcium channel blockers, beta blockers and antiepileptic drugs, 4 weeks prior to baseline until the completion of participation in the study) 7. Contraindications or inability to tolerate triptans 8. Current substance use disorder 9. Implanted metallic or electronic device in the head 10. Cardiac pacemaker or implanted or wearable defibrillator 11. 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 12. Current pregnancy or planned pregnancy (confirmed by pregnancy test and by use of safe contraception as defined by the Danish Medicines Agency) and lactation

Treatments Being Tested

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

Locations (2)

Dept. of Psychology and Behavioural Sciences
Aarhus C, Denmark
Department of Clinical Medicine, Aarhus University Hospital
Aarhus N, Denmark