NCT01637662

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

July 7, 2012

Last Update Submit

July 27, 2015

Conditions

HeadacheMigraine

Outcome Measures

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.

    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)

    10 hours after discharge

Study Arms (1)

Healthy subjects

EXPERIMENTAL
Drug: Natriuretic peptides

Interventions

Natriuretic peptidesDRUG

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

Healthy subjects

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Aged 18-40
  • Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

HeadacheMigraine Disorders

Interventions

Natriuretic Peptides

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

DK(1)