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Recruiting Not applicable

Substance P-Induced Migraine Attacks Without Aura

NCT06959004 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-05-13
Last updated
2025-06-05

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

Substance P →Placebo

Substance P: The participants will receive a continuous intravenous infusion of 20 mL of substance P (4.0 pmol/kg/min) over 20 minutes.

Placebo: The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache * Any history of moderate to severe traumatic brain injury * Any history of cardiovascular disease, including cerebrovascular diseases * Any history of pulmonary disease * Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results * The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * Female subjects of childbearing potential with a positive pregnancy test during any study visit * Cardiovascular disease of any kind, including cerebrovascular diseases * Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day * Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg) * Daily use of any medication other than contraceptives * Intake of any medication other than contraceptives within 48 hours of infusion start * Headache of any intensity within 48 hours of infusion start * Migraine attack within 5 days of infusion start * Aura within 48 hours of infusion start

Primary outcome measure(s)

  • Incidence of migraine attacks without aura — 12 hours
    The difference in the incidence of migraine attacks without aura between substance P and placebo during the 12-hour observational period after infusion start.

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Glostrup Glostrup Municipality Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06959004 on ClinicalTrials.gov ↗ ← All trials in Denmark