An interventional study of PACAP27 and Placebo in Headache, Migraine, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Other
Studying Pituitary adenylate cyclase-activating peptide 27 (PACAP27) effects on extra- and intracerebral arteries assessed by MRA on healthy volunteers.
PACAP neuropeptide, which belongs to the vasoactive intestinal polypeptide (VIP)/glucagon/secretin family. PACAP exists in two forms: Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38), which consists of 38 amino acids and PACAP27 which contains 27 amino acids at its N-terminus. PACAP38 is implicated in migraine pathophysiology however PACAP27 is not studied well. Therefore, the investigators will study PACAP27's effect on extra- and intracerebral arteries assessed by MRA on healthy volunteers.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 18 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
12 healthy volunteers will receive PACAP27 (10 picomole/kg/min) over 20 min
Other: PACAP27
6 healthy volunteers will receive placebo (Saline) over 20 min
Other: Placebo
PACAP27 is vasodilator of cerebral vessels
Saline
Dilation of extra- and intracerebral arteries
A single-slab 3D time-of-flight (3D TOF) MRA of extra- and intracranial arteries will be acquired as described in previous studies (Amin et al., 2013, 2014). MRA data will be analyzed by LKEB-MRA vessel wall analysis software program. We will measure the circumference of vessels in millimeter in five predefined time points (0, 20, 110, 200 and 290 min)
Time frame: 0-290 min
Headache
Headache intensity (Visual analog scale 0-10), characteristics, location and migraine associated symptoms will be recorded in questionnaire at hospital (6 hours) and post hospital (18 hours). In hospital phase, headache questionnaire will be filled every 30 min and post hospital every hour.
Time frame: 0 to 24 hours
Plan to share: No
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Danish Headache Center