Actively Recruiting
Substance P-Induced Migraine Attacks Without Aura
Led by Danish Headache Center · Updated on 2025-06-05
21
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Substance P-Induced Migraine Attacks Without Aura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years upon entry into screening
- Body weight between 50 and 100 kilograms
- History of migraine without aura for at least 12 months according to ICHD-3
- Experiencing between 1 and 5 migraine days without aura per month on average over the 3 months before screening
You will not qualify if you...
- History of any primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache
- History of moderate to severe traumatic brain injury
- History of cardiovascular disease, including cerebrovascular diseases
- History of pulmonary disease
- Any other clinically significant disorders or conditions that could affect safety or study results as judged by the investigator
- Risk of self-harm or harm to others based on past suicidal behavior
- Female participants of childbearing potential with a positive pregnancy test during any study visit
- Hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg before infusion
- Hypotension with systolic blood pressure ≤90 mmHg or diastolic blood pressure ≤50 mmHg
- Daily use of medications other than contraceptives
- Use of any medication other than contraceptives within 48 hours before infusion
- Headache of any intensity within 48 hours before infusion
- Migraine attack within 5 days before infusion
- Aura within 48 hours before infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
H
Haidar Al-Khazali, MD
CONTACT
H
Hakan Ashina, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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