Induction of Migraine Attacks With Aura Using Pituitary Adenylate Cyclase Activating Polypeptide-38
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Headache Center
About this trial
Pituitary Adenylate Cyclase Activating Polypeptide-38 (PACAP-38) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether PACAP-38 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
- Pituitary Adenylate Cyclase Activating Polypeptide-38 (PACAP-38)
- Placebo
Treatment groups
21 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov