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Completed

NCT Number: NCT03560024

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

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

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Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACAP27

Other

PACAP27 is vasodilator of cerebral vessels

Placebo

Other

Saline

Primary outcomes

  1. Dilation of extra- and intracerebral arteries

    Time frame: 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 outcomes

  1. Headache

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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