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New treatment option for Migraine
Official title Substance P-Induced Migraine Attacks Without Aura
ClinicalTrials.gov ID: NCT06959004
What this study is testing
What is Substance P?
Substance P is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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...
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
See the full eligibility 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
- 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...
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female people 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
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.