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

This study is currently recruiting participants.

Verified by Danish Headache Center, August 2008

Sponsored by:	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

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Acetylcholine Acetylcholine chloride Carbachol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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

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
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental	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

Contacts

Contact: Henrik Schytz, MD

+4528761824

hewisc01@glo.regionh.dk

Locations

Denmark
Danish Headache Center	Recruiting
Glostrup, Denmark, 2600
Contact: Henrik Schytz, MD +4528761824 hewisc01@glo.regionh.dk
Principal Investigator: Henrik Schytz, MD

Sponsors and Collaborators

Danish Headache Center

Investigators

Principal Investigator:

Henrik Schytz, MD

Danish Headache Center

More Information

Responsible Party:	Danish HC ( Henrik Schytz/MD )
Study ID Numbers:	HC20070049
Study First Received:	November 27, 2007
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00564408
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Signs and Symptoms
Migraine Disorders
Headache
Neurologic Manifestations

Acetylcholine
Pain
Carbachol

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Miotics
Nervous System Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Cholinergic Agents

Protective Agents
Pharmacologic Actions
Sensory System Agents
Analgesics, Non-Narcotic
Autonomic Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009