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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637662
First Posted: July 11, 2012
Last Update Posted: July 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Song Guo, Danish Headache Center
  Purpose
To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.

Condition Intervention
Headache Migraine Drug: Natriuretic peptides

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Song Guo, 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. ]

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 ]

Enrollment: 6
Study Start Date: July 2012
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637662


Locations
Denmark
Danish Headache Center
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
  More Information

Responsible Party: Song Guo, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01637662     History of Changes
Other Study ID Numbers: H-3-2012-065
First Submitted: July 7, 2012
First Posted: July 11, 2012
Last Update Posted: July 29, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms