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The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects

D

Danish Headache Center

Status

Completed

Conditions

Headache

Treatments

Other: Ketorolac
Other: Sumatriptan

Study type

Interventional

Funder types

Other

Identifiers

NCT03585894
H-18008313

Details and patient eligibility

About

Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac assessed by magnetic resonance imaging (MRI) on healthy volunteers.

Full description

The purpose of this research project is to investigate the importance of blood vessel (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac (NSAID). In addition, we will investigate headache-related changes in the brain's network connectivity.

Enrollment

34 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

Crossover Assignment

Masking

Triple Blind

34 participants in 2 patient groups

Sumatriptan
Other group
Description:
Sumatriptan 4 mg/mL I.V will be administrated over 10 min
Treatment:
Other: Sumatriptan
Ketorolac
Active Comparator group
Description:
Ketorolac 30 mg/mL I.V will be administrated over 10 min
Treatment:
Other: Ketorolac

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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