Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

This study is currently recruiting participants.
Verified April 2013 by Danish Headache Center
Information provided by (Responsible Party):
Song Guo, Danish Headache Center Identifier:
First received: July 7, 2012
Last updated: April 26, 2013
Last verified: April 2013

To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.

Condition Intervention
Drug: Natriuretic peptides

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Mechanisms and Biological Markers During Headache Induced by Natriuretic Peptides

Resource links provided by NLM:

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion. [ Time Frame: Every 10 min. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All subjects were asked to complete a headache diary every hour until 10 h after the discharge. The diary included headache characteristics and accompanying symptoms according to the International Headache Society (IHS 2004) [ Time Frame: 10 hours after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy subjects Drug: Natriuretic peptides
I.V. infusion between 0.2-3 microgram over 20 minutes


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers
  • Aged 18-40
  • 50-100 kg
  • Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

  • Tension type headache more than once/month
  • Other primary headaches
  • Daily medication except contraceptives
  • Drug taken within 4 times the halflife 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01637662

Contact: Song Guo, MD +45 60887727

Danish Headache Center Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Song Guo, MD    +45 60887727   
Principal Investigator: Song Guo, MD         
Sponsors and Collaborators
Danish Headache Center
  More Information

No publications provided

Responsible Party: Song Guo, MD, Danish Headache Center Identifier: NCT01637662     History of Changes
Other Study ID Numbers: H-3-2012-065
Study First Received: July 7, 2012
Last Updated: April 26, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Migraine Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases processed this record on April 17, 2014