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

The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by MRA on Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03560024

Enrollment

Registered

2018-06-18

Start date

2018-05-31

Completion date

2018-12-31

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine

Brief summary

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

Detailed description

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.

Interventions

OTHERPACAP27

PACAP27 is vasodilator of cerebral vessels

OTHERPlacebo

Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Dilation of extra- and intracerebral arteries	0-290 min	A single-slab 3D time-of-flight (3D TOF) MRA of extra- and intracranial arteries will be acquired as described in previous studies (Amin et al., 2013, 2014). MRA data will be analyzed by LKEB-MRA vessel wall analysis software program. We will measure the circumference of vessels in millimeter in five predefined time points (0, 20, 110, 200 and 290 min)

Secondary

Measure	Time frame	Description
Headache	0 to 24 hours	Headache intensity (Visual analog scale 0-10), characteristics, location and migraine associated symptoms will be recorded in questionnaire at hospital (6 hours) and post hospital (18 hours). In hospital phase, headache questionnaire will be filled every 30 min and post hospital every hour.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026