Pain Clinical Trial
Official title:
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Episodic Migraine Patients Without Aura
Verified date | October 2020 |
Source | Danish Headache Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vasoactive intestinal peptide (VIP) is a peptide of 28 amino acid residues that belongs to the glucagon/secretin superfamily of peptides. Along with other neuropeptides, such as calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP), it is released from the trigeminal afferents and exerts a strong vasodilating activity on the cranial vasculature. Especially, it shares 70% structure with PACAP and acts on the same receptors. But, unlike it, VIP cannot induce a long-lasting vasodilation and has a modest capability to induce migraine attacks. Whether it may induce migraine-like attacks in migraine patients, as a twenty-minute infusion of PACAP, is unknown.
Status | Completed |
Enrollment | 21 |
Est. completion date | September 15, 2020 |
Est. primary completion date | September 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Diagnosis of migraine without aura as according to the International Classification - Frequency of migraine attacks between one and six attacks within 8 weeks - Weight: 50-90 kg - Fertile women should use contraception. Fertile women do not include hysterectomies women or women who are postmenopausal for at least 2 years. Contraception includes either IUD, birth control pills, surgical sterilization of the woman or depot progesterone Exclusion Criteria: - Any other type of headache (including > 2 days of tension-type headache per month) - Headache less than 48 hours before the start of the experiment - Daily intake of any medicine other than oral contraception - Pregnant or breastfeeding women - Clinical signs of Hypertension (systolic blood pressure > 150 mmHg and / or diastolic blood pressure > 100 mmHg) and/or 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, abuse or smoking |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center | Glostrup | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of migraine-like attacks | Migraine-like attack fulfilling either (i) or (ii):
(i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification od Headache Disorders: C. Headache has at least two of the following four characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate pain intensity is considered 5 or 4 on verbal rating scale); aggravation by cough (hospitalization phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication). |
Before (-10 minutes) and after the drug administration (+12 hours) | |
Secondary | Change in cranial hemodynamic | Change on diameter (mm) of superficial temporal artery (STA) | Before (-10 minutes) and after the drug administration (+3 hours) | |
Secondary | Occurrence of headache and change of headache intensity scores | Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no headache; 1 is a very mild headache, including a feeling of pressing or throbbing; 5 is a moderate headache; 10 is the worst imaginable headache. | Before (-10 minutes) and after the drug administration (+12 hours) | |
Secondary | Change in Mean Arterial Pressure | Blood pressure was measured using an auto-inflatable cuff (Protocol, Oregon, USA). Blood pressure was registered as mean arterial pressure (MAP), equal to diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure). | Before (-10 minutes) and after the drug administration (+3 hours and 20 minutes) | |
Secondary | Change in Heart Rate | Heart rate was measured using an auto-inflatable cuff (Protocol, Oregon, USA). | Before (-10 minutes) and after the drug administration (+3 hours and 20 minutes) |
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