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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
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01637662
First received: July 7, 2012
Last updated: April 26, 2013
Last verified: April 2013
History of Changes

July 7, 2012
April 26, 2013
July 2012
January 2014   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT01637662 on ClinicalTrials.gov Archive Site
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 ]
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Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Mechanisms and Biological Markers During Headache Induced by Natriuretic Peptides

To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.
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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
  • Headache
  • Migraine
Drug: Natriuretic peptides
I.V. infusion between 0.2-3 microgram over 20 minutes
Experimental: Healthy subjects
Intervention: Drug: Natriuretic peptides
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
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January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact: Song Guo, MD +45 60887727 song60887727@gmail.com
Denmark
 
NCT01637662
H-3-2012-065
No
Song Guo, Danish Headache Center
Danish Headache Center
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Danish Headache Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP