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

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ClinicalTrials.gov Identifier: NCT03560024
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hashmat Ghanizada, Danish Headache Center

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

Condition or disease Intervention/treatment Phase
Headache, Migraine Other: PACAP27 Other: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 18 healthy volunteers will receive PACAP27 or placebo. All Data will also be analyses blinded.
Masking: Double (Participant, Investigator)
Masking Description: Randomized, double-blind placebo-controlled design in healthy volunteers.
Primary Purpose: Other
Official Title: The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by MRA on Healthy Volunteers
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: PACAP27
12 healthy volunteers will receive PACAP27 (10 picomole/kg/min) over 20 min
Other: PACAP27
PACAP27 is vasodilator of cerebral vessels

Placebo Comparator: Placebo
6 healthy volunteers will receive placebo (Saline) over 20 min
Other: Placebo
Saline




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560024


Contacts
Contact: Hashmat Ghanizada, MD 0045-38633470 hashmat.ghanizada@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Hashmat Ghanizada, MD    0045-51447278    hashmat.ghanizada@regionh.dk   
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Hashmat Ghanizada, Principal Investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03560024     History of Changes
Other Study ID Numbers: H-18016693
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action