Back to resultsNatriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Primary Purpose
Headache, Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Natriuretic peptides
Sponsored by
About this trial
This is an interventional screening trial for Headache
Eligibility 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
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy subjects
Arm Description
Outcomes
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01637662
Brief Title
Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Official Title
Mechanisms and Biological Markers During Headache Induced by Natriuretic Peptides
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Natriuretic peptides
Intervention Description
I.V. infusion between 0.2-3 microgram over 20 minutes
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
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Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
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