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

Migraine Clinical Trial

Official title:

Mechanisms and Biological Markers During Headache Induced by Natriuretic Peptides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637662
• Other study ID #: H-3-2012-065
• Status: Completed
• Phase: N/A
• First received: July 7, 2012
• Last updated: July 27, 2015
• Start date: July 2012

Study information

• Verified date: July 2015
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

Drug:
• Natriuretic peptides
I.V. infusion between 0.2-3 microgram over 20 minutes

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Every 10 min.	No
Secondary	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)		10 hours after discharge	No