Trial Designs for Evaluating Migraine Treatment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Dept. of Psychology and Behavioural Sciences
NOT_YET_RECRUITING
Aarhus C
Department of Clinical Medicine, Aarhus University Hospital
RECRUITING
Aarhus N
Contact Information
Primary
Sigrid Juhl Lunde, MSc, PhD
lunde@psy.au.dk
4587165956
Backup
Simple F Kothari, BDS, MSc, PhD
simple.futarmal@psy.au.dk
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2028-09
Participants
Target number of participants: 128
Treatments
Active_comparator: Active group
Active drug
Placebo_comparator: Placebo group
Inactive placebo
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov