Status:
COMPLETED
PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea
Lead Sponsor:
Danish Headache Center
Conditions:
Rosacea
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatripta...
Detailed Description
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in rosacea pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in migraine patients. PACAP38 also induces f...
Eligibility Criteria
Inclusion
- diagnosed with rosacea
- weight between 50 - 100 kilograms
- women in fertile age must not be pregnant and must use adequate contraception
Exclusion
- 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
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03878784
Start Date
November 12 2018
End Date
December 19 2019
Last Update
March 26 2020
Active Locations (1)
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1
DanishHC
Glostrup Municipality, Denmark, DK-2600