Hypersensitivity to Adrenomedullin in Post- Traumatic Headache: A Randomized Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Adrenomedullin is a neuropeptide implicated in the pathogenesis of headache. This study investigates whether adrenomedullin induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
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
• History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
• ≥ 4 monthly headache days on average across the 3 months prior to screening
• Provision of informed consent prior to initiation of any study-specific activities/procedures.
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: 2025-08-01
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 21
Treatments
Experimental: Adrenomedullin
Adrenomedullin will be administered by intravenous infusion.
Placebo_comparator: Placebo
Placebo (isotonic saline) will be administered by intravenous infusion.
Related Therapeutic Areas
Sponsors
Leads: Danish Headache Center