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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564408
First Posted: November 28, 2007
Last Update Posted: August 3, 2009
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.
Information provided by:
Danish Headache Center
  Purpose
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 Intervention
Headache Drug: Carbachol

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

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

Estimated Enrollment: 12
Study Start Date: August 2007
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: Carbachol
3 microgram per kg bodyweight infused intravenously

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
  Eligibility

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
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
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Henrik Schytz, MD Danish Headache Center
  More Information

Responsible Party: Henrik Schytz/MD, Danish HC
ClinicalTrials.gov Identifier: NCT00564408     History of Changes
Other Study ID Numbers: HC20070049
First Submitted: November 27, 2007
First Posted: November 28, 2007
Last Update Posted: August 3, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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