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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01637662
First received: July 7, 2012
Last updated: June 5, 2014
Last verified: June 2014
  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
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
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637662

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

No publications provided

Responsible Party: Song Guo, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01637662     History of Changes
Other Study ID Numbers: H-3-2012-065
Study First Received: July 7, 2012
Last Updated: June 5, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014