Substance P is a signaling molecule that has been implicated in the pathogenesis of headache. This study aims to ascertain whether administration of substance P can induce headache in healthy adults.
Substance P is a vasoactive signaling molecule that belongs to the tachykinin family of peptides. It is expressed in multiple cells, including primary afferents of the trigeminal ganglion that innervate the meninges and its arteries. The best-known function of substance P is its role in pain transmission, and several lines of evidence has implicated substance P in the pathogenesis of headache. This study aims to ascertain whether intravenous infusion of substance P induces headache in healthy individuals who have no past or current history of primary or secondary headache disorder, except for infrequent episodic tension-type headache. For this purpose, we will conduct a randomized, double-blind, placebo-controlled, 2-way crossover trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
21
The participants will receive a continuous intravenous infusion of 20 mL of substance P (1.5 pmol/kg/min) over 20 minutes.
The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.
Danish Headache Center, Copenhagen University Hospital - Rigshospitalet
Glostrup Municipality, Denmark
Incidence of Headache
The primary outcome is the difference in the incidence of headache\* between substance P and placebo during the 12-hour observational period after infusion start. \* The intensity of headache is rated by the subject on the 11-point numerical rating scale (0 being no headache, 10 being the worst imaginable headache).
Time frame: 12 hours
Headache Intensity Scores
The secondary outcome is the difference in the area under the curve for median headache intensity scores between substance P and placebo during the 12-hour observational period after infusion start.
Time frame: 12 hours
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