The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by Magnetic Resonance Angiography (MRA) on Healthy Volunteers

NCT ID: NCT03560024

Last Updated: 2019-02-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2018-12-31

Brief Summary

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Studying Pituitary adenylate cyclase-activating peptide 27 (PACAP27) effects on extra- and intracerebral arteries assessed by MRA on healthy volunteers.

Detailed Description

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PACAP neuropeptide, which belongs to the vasoactive intestinal polypeptide (VIP)/glucagon/secretin family. PACAP exists in two forms: Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38), which consists of 38 amino acids and PACAP27 which contains 27 amino acids at its N-terminus. PACAP38 is implicated in migraine pathophysiology however PACAP27 is not studied well. Therefore, the investigators will study PACAP27's effect on extra- and intracerebral arteries assessed by MRA on healthy volunteers.

Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

18 healthy volunteers will receive PACAP27 or placebo. All Data will also be analyses blinded.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Randomized, double-blind placebo-controlled design in healthy volunteers.

Study Groups

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PACAP27

12 healthy volunteers will receive PACAP27 (10 picomole/kg/min) over 20 min

Group Type ACTIVE_COMPARATOR

PACAP27

Intervention Type OTHER

PACAP27 is vasodilator of cerebral vessels

Placebo

6 healthy volunteers will receive placebo (Saline) over 20 min

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Interventions

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PACAP27

PACAP27 is vasodilator of cerebral vessels

Intervention Type OTHER

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria

* Tension type headache more than 5 dag /month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the half-life for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Primary relatives with current or previous migraine
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Hashmat Ghanizada

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18016693

Identifier Type: -

Identifier Source: org_study_id

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