PACAP27 Headache Properties in Migraine Without Aura Patients

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Pituitary Adenylate Cyclase-Activating Polypeptide

Criteria

Inclusion Criteria:

• Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.

• Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion Criteria:

• Tension Type headache for more than 5 days the month on average in the last year.

• All other primary headaches .

• Headache later than 48 hours before trial start.

• Daily intake of any medicine other than oral contraception.

• Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.

• Pregnant or breastfeeding women.

• Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo

• Migraine within 5 days before the trial date.

• Ancestral information or clinical signs of (on the day of inclusion):

• Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)

• Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)

• Cardiovascular disease of all kinds, including cerebrovascular disease.

• Anamnestic or clinical signs of mental illness or abuse.

• Patients with glaucoma or prostatic hyperplasia

• Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.