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Testing Substance P to See if It Triggers Migraine Attacks

Tests whether substance P can trigger migraine attacks in adults with migraine without aura.

Plain-language title generated from the registry record
Registry title: Substance P-Induced Migraine Attacks Without Aura

Key facts

Where
Glostrup Municipality, DenmarkSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT06959004, who can take part

Where in Denmark

  • Rigshospitalet GlostrupGlostrup Municipality, DenmarkTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Danish Headache Center
Trial code
NCT06959004
Record updated
5 June 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; Daily use of any medication other than contraceptives; Intake of any medication other than contraceptives within 48 hours of infusion start; 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; Cardiovascular disease of any kind, including cerebrovascular diseases; 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; Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg); 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.

ClinicalTrials.gov NCT06959004