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

July 31, 2009 updated by: Danish Headache Center

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

The purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Migraine without aura
  • Weight 50-100 kg

Exclusion Criteria:

  • Other significant diseases
  • Migraine 5 days prior to experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Drug: Carbachol
3 microgram per kg bodyweight infused intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache response after Carbachol infusion
Time Frame: 1 day after infusion
1 day after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Henrik Schytz, MD, Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Estimate)

August 3, 2009

Last Update Submitted That Met QC Criteria

July 31, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC20070049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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