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Induction of Migraine Attacks With Aura Using Pituitary Adenylate Cyclase Activating Polypeptide-38

ConditionsMigraine With AuraMigraine Aura
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Pituitary Adenylate Cyclase Activating Polypeptide-38 (PACAP-38)

    Drug

    The participants will receive a continuous intravenous infusion of 10 pmol/kg/min PACAP-38 over 20 min

  • Placebo

    Drug

    The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Pituitary Adenylate Cyclase Activating Polypeptide-38 (PACAP-38)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of migraine attacks with aura

Difference in incidence of migraine attack with aura between PACAP-38 and placebo during the 12-hour observational period after infusion start. Experimentally induced migraine aura is defined as aura that meet Criteria B and C of 1.2 Migraine with Aura in ICHD-3.

Time frame
12 hours

Secondary outcomes

1

Incidence of migraine attacks without aura

Difference in incidence of migraine pain (headache) between PACAP-38 and placebo during the 12-hour observational period after infusion start. Experimentally induced migraine pain is defined as headache that meet Criteria C and D of 1.1. Migraine without Aura in ICHD-3 as well as resembles the subject's usual migraine attack or is treated with an acute headache medication.

Time frame
12 hours
2

Headache intensity scores

Difference in area under the curve (AUC) for headache intensity scores between PACAP-38 and placebo during the 12-hour observational period after infusion start. The intensity of headache is rated by the subject on the 11-point numerical rating scale (0 being no headache, 10 being the worst imaginable headache).

Time frame
12 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Headache Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: