Investigating the role of Substance P in triggering migraine attacks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the effects of Substance P, a neuropeptide linked to headache mechanisms, on individuals with migraine without aura. Participants will receive intravenous infusions of Substance P or a placebo in a randomized, double-blind, placebo-controlled, two-way crossover design. The goal is to determine if Substance P can induce migraine attacks in those with a history of this condition. The study aims to enhance understanding of migraine pathophysiology and potential treatment avenues.

Why it matters

Who can join: the full rules

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

Where it's running

• Rigshospitalet Glostrup
  Glostrup Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Haidar Al-Khazali, MD
• Email: haidardk@hotmail.com
• Phone: +4541598494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.