Investigating the role of Substance P in triggering migraine attacks
Substance P-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial
This study is trying to see if a substance called Substance P can trigger migraine attacks in people who usually get migraines without aura.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Danish Headache Center Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT06959004 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a history of migraine without aura and experiencing 1-5 migraine days per month.
Not a fit: Patients with other primary or secondary headache disorders, significant medical histories, or conditions that could interfere with the study will not benefit.
Why it matters
Potential benefit: If successful, this study could lead to new insights into migraine triggers and potential therapeutic targets for patients suffering from migraines.
How similar studies have performed: While the role of Substance P in headache mechanisms has been studied, this specific approach of inducing migraine attacks through its administration is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Glostrup Municipality
- Rigshospitalet Glostrup — Glostrup Municipality, Denmark (Recruiting)
Study contacts
- Study coordinator: Haidar Al-Khazali, MD
- Email: haidardk@hotmail.com
- Phone: +4541598494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.