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

This study has been completed.

First Received on November 27, 2007. Last Updated on July 31, 2009 History of Changes

Sponsor:	Danish Headache Center
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00564408

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 Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Carbachol

U.S. FDA Resources

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:

Headache response after Carbachol infusion [ Time Frame: 1 day after infusion ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Henrik Schytz/MD, Danish HC
ClinicalTrials.gov Identifier:	NCT00564408 History of Changes
Other Study ID Numbers:	HC20070049
Study First Received:	November 27, 2007
Last Updated:	July 31, 2009
Health Authority:	Denmark: Ethics Committee

Additional relevant MeSH terms:

Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Carbachol
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012