PACAP27 Headache Properties in Migraine Without Aura Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients

Conditions
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Migraine Without Aura

Intervention / Treatment
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* Drug: PACAP27
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>PACAP-27 | Drug: PACAP27<br>* Infusion of PACAP27 over 20 minutes.<br>|
| Placebo Comparator: Placebo<br>Saline | Drug: Saline<br>* Infusion of Saline over 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Scores | Comparison between PACAP27 and Placebo | 0-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial blood flow (flushing) | PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging | 0-120 mins |