Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
21 (estimated)
Sponsor
Danish Headache Center · Other
Who this trial is looking for
This trial is looking for people aged 18 to 65 who have migraine without aura. Participants will receive a substance to see if it triggers a migraine attack.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I weigh between 50 and 100 kg.
I have had migraine without aura for at least 12 months.
I have 1 to 5 migraine days without aura each month.
You may not be able to join if
I have a history of headaches other than migraine without aura.
I have had a moderate to severe brain injury.
I have a history of cardiovascular disease.
I have a history of pulmonary disease.
I am at risk of self-harm or harming others.
I am female and have a positive pregnancy test.
I have high blood pressure before the study starts.
I have had a headache in the last 48 hours.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 Cri…
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
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