NCT06959004 Substance P-Induced Migraine Attacks Without Aura
| NCT ID | NCT06959004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Headache Center |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 21 participants in total. It began in 2025-05-13 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06959004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06959004 currently recruiting?
Yes, NCT06959004 is actively recruiting participants. Contact the research team at haidardk@hotmail.com for enrollment information.
Where is the NCT06959004 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark.
Who is sponsoring the NCT06959004 clinical trial?
NCT06959004 is sponsored by Danish Headache Center. The trial plans to enroll 21 participants.
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