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

Headache, Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560024
• Other study ID #: H-18016693
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Other:
• PACAP27
PACAP27 is vasodilator of cerebral vessels
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Headache	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.	0 to 24 hours