Migraine Disorders Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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