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Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00357864
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : August 30, 2007
Sponsor:
Information provided by:
Danish Headache Center

Tracking Information
First Submitted Date July 26, 2006
First Posted Date July 28, 2006
Last Update Posted Date August 30, 2007
Study Start Date July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Official Title Basic Research on Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow in a Humane Experimental Headache Model
Brief Summary To investigate headache score and accompanying symptoms during and after infusion of carbachol.
Detailed Description

To investigate headache score and accompanying symptoms during and after infusion of carbachol.

Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Headache
Intervention Drug: carbachol
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2006)		 15
Original Enrollment Same as current
Actual Study Completion Date April 2007
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00357864
Other Study ID Numbers 2006-002462-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor Danish Headache Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: henrik schytz Danish Headache Center
PRS Account Danish Headache Center
Verification Date August 2007