Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Headache Center

About this trial

Calcitonin gene-related peptide (CGRP) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether CGRP administration can trigger aura in individuals with a diagnosis of migraine with aura.

Eligibility criteria

Qualifiers

Age 18 to 65 years of age upon entry into screening

History of migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria

≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening

Provision of informed consent prior to initiation of any study-specific activities/procedures.

Disqualifiers

Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache

History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion

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

Trial design

Treatments tested in this trial

  • Calcitonin-gene related peptide (CGRP)
  • Placebo

Treatment groups

21 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Danish Headache Center

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution