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Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients

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: NCT00564408
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : August 3, 2009
Sponsor:
Information provided by:
Danish Headache Center

Tracking Information
First Submitted Date  ICMJE November 27, 2007
First Posted Date  ICMJE November 28, 2007
Last Update Posted Date August 3, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
Headache response after Carbachol infusion [ Time Frame: 1 day after infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2007)
Headache respons after carbachol infusion [ Time Frame: 1 day after infusion ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients
Official Title  ICMJE Experimental Study That Investigates the Effect of an Acetylcholine Analogue in Terms of Headache and Changes in Intra- and Extra-cerebral Vessels During and After Infusion of Carbachol
Brief Summary The purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.
Detailed Description To test if infusion of Carbachol induces headache in 12 migraine subjects as well as intra- and extra-cerebral vasodilatation in a double-blinded study
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Headache
Intervention  ICMJE Drug: Carbachol
3 microgram per kg bodyweight infused intravenously
Study Arms  ICMJE Experimental: I
Intervention: Drug: Carbachol
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  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 27, 2007)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Migraine without aura
  • Weight 50-100 kg

Exclusion Criteria:

  • Other significant diseases
  • Migraine 5 days prior to experiment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00564408
Other Study ID Numbers  ICMJE HC20070049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Henrik Schytz/MD, Danish HC
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Danish Headache Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henrik Schytz, MD Danish Headache Center
PRS Account Danish Headache Center
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP