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

Tracking Information

First Received Date ^ICMJE

November 27, 2007

Last Updated Date

July 31, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Headache respons after carbachol infusion [ Time Frame: 1 day after infusion ]

Change History

Complete list of historical versions of study NCT00564408 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Headache

Intervention ^ICMJE

Drug: Carbachol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2009

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00564408

Responsible Party

Henrik Schytz/MD, Danish HC

Study ID Numbers ^ICMJE

HC20070049

Study Sponsor ^ICMJE

Danish Headache Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Henrik Schytz, MD

Danish Headache Center

Information Provided By

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