Abstract
Background Trigeminal neuralgia (TN) is a chronic disorder characterized by paroxysmal facial pain. Adequate prophylactic drug therapy is often limited by the lack of efficacy and intolerance due to central nervous system side effects. Subcutaneous injections of botuinum toxin type A (BT-A) are a promising treatment option for patients with insatisfactory response to drug therapy or neurosurgical intervention. This is the study protocoll of a prospective, placebocontrolled, double blind clinical trial investigating the add-on therapy of subcutaneous of BT-A injections to standard treatment.
Highlights
Trigeminal neuralgia (TN) is a chronic disorder characterized by paroxysmal facial pain
Adequate prophylactic drug therapy is often limited by the lack of efficacy and intolerance due to central nervous system side effects
In the first phase phase all patients will receive verum in a single blinded intervention and twelve weeks later therapy responders will be 1:1 allocated to the verum or placebo arm. This time the intervention is double blind and injections will be done at the same sites
Summary
Study protocol of BoTN: a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of botulinum toxin injections in the treatment of trigeminal neuralgia. From 4th European Headache and Migraine Trust International Congress: EHMTIC 2014 Copenhagen, Denmark. From 4th European Headache and Migraine Trust International Congress: EHMTIC 2014 Copenhagen, Denmark. 18-21 September 2014
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