Back to resultsCarbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients
Primary Purpose
Headache
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Carbachol
Sponsored by
About this trial
This is an interventional basic science trial for Headache
Eligibility Criteria
Inclusion Criteria:
- Migraine without aura
- Weight 50-100 kg
Exclusion Criteria:
- Other significant diseases
- Migraine 5 days prior to experiment
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I
Arm Description
Outcomes
Primary Outcome Measures
Headache response after Carbachol infusion
Secondary Outcome Measures
Full Information
NCT ID
NCT00564408
First Posted
November 27, 2007
Last Updated
July 31, 2009
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT00564408
Brief Title
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carbachol
Intervention Description
3 microgram per kg bodyweight infused intravenously
Primary Outcome Measure Information:
Title
Headache response after Carbachol infusion
Time Frame
1 day after infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Migraine without aura
Weight 50-100 kg
Exclusion Criteria:
Other significant diseases
Migraine 5 days prior to experiment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Schytz, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients
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