Overview

PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

Status:
Completed
Trial end date:
2019-12-07
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Danish Headache Center
Treatments:
Pituitary Adenylate Cyclase-Activating Polypeptide
Sumatriptan
Criteria
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