PACAP27 Headache Properties in Migraine Without Aura Patients
NCT ID: NCT03471039
Last Updated: 2019-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-08-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Active
PACAP-27
PACAP27
Infusion of PACAP27 over 20 minutes.
Placebo
Saline
Saline
Infusion of Saline over 20 minutes.
Interventions
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PACAP27
Infusion of PACAP27 over 20 minutes.
Saline
Infusion of Saline over 20 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Hashmat Ghanizada
Principal Investigator
Locations
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Danish Headache Center
Glostrup Municipality, , Denmark
Countries
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Other Identifiers
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H-17016232
Identifier Type: -
Identifier Source: org_study_id
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