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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03471039
Other study ID # H-17016232
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2017
Est. completion date September 30, 2018

Study information

Verified date January 2019
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PACAP27
Infusion of PACAP27 over 20 minutes.
Saline
Infusion of Saline over 20 minutes.

Locations

Country Name City State
Denmark Danish Headache Center Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Headache Scores Comparison between PACAP27 and Placebo 0-12 hours
Secondary Facial blood flow (flushing) PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging 0-120 mins
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