PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

Danish Headache Center

Status: Completed

Conditions: Migraine Without Aura

Treatments: Drug: Imigran; Other: Isotonic Saline; Other: Pituitary adenylate cyclase-activating peptide-38

Study type: Interventional

Funder types: Other

Identifiers

NCT03881644

MigRosExperiment

Details and patient eligibility

About

The aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with migraine

Full description

Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. We are investigating whether treatment with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and migraine is induced.

The purpose of this study is to investigate PACAP38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The study will be conducted with a double-blind, placebo-controlled crossover study design.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of migraine, according to IHS criteria
• weight between 50 - 100 kilograms
• women in fertile age must not be pregnant and must use adequate contraception

Exclusion criteria

• migraine more than 5 days per month in average over the past year
• any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
• headache < 48 hours before experimental day
• migraine < 72 hours before each experimental day
• daily / frequent use of any medication apart from contraceptive medication
• use of any drug less than 5 times the half-life of the drug at the time of the experiment
• women who are pregnant or breast-feeding at the time of the experiment
• anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or
• diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
• anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
• patients with glaucoma or prostate hyperplasia
• anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

PACAP38 + Imigran

Active Comparator group

Description:

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Imigran infusion (0.4 mg/min) for 10 mins

Treatment:

Other: Pituitary adenylate cyclase-activating peptide-38

Drug: Imigran

PACAP38 + Isotonic Saline

Placebo Comparator group

Description:

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo)

Treatment:

Other: Pituitary adenylate cyclase-activating peptide-38

Other: Isotonic Saline