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Completed

NCT Number: NCT01637662

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

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

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natriuretic peptides

Drug

I.V. infusion between 0.2-3 microgram over 20 minutes

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Mechanisms and Biological Markers During Headache Induced by Natriuretic Peptides

Important dates

Study start
2012
Primary completion
2014
First posted
Jul 11, 2012
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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