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NCT00564408 Clinical Trial

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

Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00564408
Other study ID # HC20070049
Secondary ID
Status Completed
Phase N/A
First received November 27, 2007
Last updated July 31, 2009
Start date August 2007
Est. completion date February 2009

Study information
Verified date July 2009
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Migraine without aura

- Weight 50-100 kg

Exclusion Criteria:

- Other significant diseases

- Migraine 5 days prior to experiment

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Carbachol
3 microgram per kg bodyweight infused intravenously

Locations
Country Name City State
Denmark Danish Headache Center Glostrup

Sponsors (1)
Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Headache response after Carbachol infusion 1 day after infusion No
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