Substance P-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Substance P is a neuropeptide implicated in the pathogenesis of headache. This study investigates whether its administration can trigger migraine attacks in individuals with migraine without aura.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age 18 to 65 years of age upon entry into screening
• A body weight of 50 to 100 kg
• History of migraine without aura for ≥12 months and in accordance with ICHD-3
• Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening
Locations
Other Locations
Denmark
Rigshospitalet Glostrup
RECRUITING
Glostrup Municipality
Contact Information
Primary
Haidar Al-Khazali, MD
haidardk@hotmail.com
+4541598494
Backup
Hakan Ashina, MD, PhD
haakan.ashina@regionh.dk
+4528102495
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 21
Treatments
Experimental: Substance P
Substance P will be administered by intravenous infusion.
Placebo_comparator: Placebo
Placebo (isotonic saline) will be administered by intravenous infusion.
Sponsors
Leads: Danish Headache Center