Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06959004

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

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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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Rigshospitalet Glostrup

Glostrup Municipality, Denmark, 2600

Actively Recruiting

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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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