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

NCT03560024 | Completed DMC

• 1 other identifier: H-18016693
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

• Dilation of extra- and intracerebral arteries

  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)

  0-290 min

Secondary Outcomes (1)

• Headache

  0 to 24 hours

Study Arms (2)

PACAP27

ACTIVE COMPARATOR

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

Other: PACAP27

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

PACAP27 OTHER

PACAP27 is vasodilator of cerebral vessels

PACAP27

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Aged 18-50

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Proteins; Nerve Tissue Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, double-blind placebo-controlled design in healthy volunteers.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 18, 2018
• Study Start: May 31, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)