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Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect. The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion. The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail. The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Department of Neuroscience, Norwegian University of Science and Technology
Trondheim, Norway
Start Date
February 1, 2015
Primary Completion Date
March 1, 2016
Completion Date
March 1, 2016
Last Updated
May 23, 2016
10
ACTUAL participants
Botulinum Toxin Type A
DRUG
Lead Sponsor
Norwegian University of Science and Technology
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05690737