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

D

Danish Headache Center

Status

Completed

Conditions

Headache, Migraine

Treatments

Other: Placebo
Other: PACAP27

Study type

Interventional

Funder types

Other

Identifiers

NCT03560024
H-18016693

Details and patient eligibility

About

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

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 2 patient groups, including a placebo group

PACAP27
Active Comparator group
Description:
12 healthy volunteers will receive PACAP27 (10 picomole/kg/min) over 20 min
Treatment:
Other: PACAP27
Placebo
Placebo Comparator group
Description:
6 healthy volunteers will receive placebo (Saline) over 20 min
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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