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

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Other: Placebo; Other: PACAP27

• Registration Number: NCT03560024
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-05-31
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	6 healthy volunteers will receive placebo (Saline) over 20 min
PACAP27	PACAP27	12 healthy volunteers will receive PACAP27 (10 picomole/kg/min) over 20 min

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark