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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Headache Drug: Carbachol Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache
Drug Information available for: Carbachol

Arms and Interventions
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Arm Intervention/treatment
Experimental: I Drug: Carbachol
3 microgram per kg bodyweight infused intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Headache response after Carbachol infusion [ Time Frame: 1 day after infusion ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine without aura
  • Weight 50-100 kg

Exclusion Criteria:

  • Other significant diseases
  • Migraine 5 days prior to experiment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564408


Locations
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Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Henrik Schytz, MD Danish Headache Center
More Information
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Responsible Party: Henrik Schytz/MD, Danish HC
ClinicalTrials.gov Identifier: NCT00564408    
Other Study ID Numbers: HC20070049
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Carbachol
Cardiotonic Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Protective Agents