NCT06959004

Substance P-Induced Migraine Attacks Without Aura

Substance P-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Substance P is a vasoactive neuropeptide of the tachykinin family, expressed in various cell types, including primary afferents of the trigeminal ganglion that innervate the meninges and associated vasculature. Its most well-established role is in nociceptive signaling, and accumulating evidence implicates substance P in the pathogenesis of headache. This study investigates whether intravenous infusion of substance P can induce migraine attacks in individuals with a history of migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Substance P	The participants will receive a continuous intravenous infusion of 20 mL of substance P (4.0 pmol/kg/min) over 20 minutes.
DRUG	Placebo	The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2025-05-06
• Last updated: 2025-06-05

Locations

1 site across 1 country: Denmark