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โ† Trials
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Substance P-Induced Migraine Attacks Without Aura

RecruitingNAAges 18 Years - 65 YearsAllDanish Headache Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ12 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 โ‰ฅ150 mmHg and/or diastolic blood pressure of โ‰ฅ100 mmHg) prior to the start of infusion on the experimental day * Hypotension (systolic blood pressure of โ‰ค90 mmHg and/or diastolic blood pressure of โ‰ค50 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
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What it tests

  • Substance P
  • Placebo
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Where

1 site
Rigshospitalet Glostrup
Glostrup Municipality, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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