Onabotulinum Toxin-A Injections for Nocturnal Bruxism: A Parallel, Double Blind, Placebo Controlled Polysomnographic Study (P05.006)

Objective: To test the safety and efficacy of onabotulinum toxin-A injections into the masseter/temporalis muscles in patients with nocturnal bruxism. Background Bruxism is probably the most common parasomnia, occurring in up to 15% of the population. There is no widely accepted treatment other than bite guards to limit dental damage. Design/Methods: We performed a double blind, placebo injection controlled (1:1) trial of onabotulinum-A (BoNT) for nocturnal bruxism. Patients underwent a baseline/screening overnight polysomnogram (PSG). They were then randomized to receive BoNT or placebo into the bilateral masseter (60u/side) and temporalis muscles (40u/side) using visual landmarks. Primary efficacy points were CGI and VAS of change at 4 weeks post injection. Secondary points including change in PSG data, including masseter placed electrodes, pain scales, sleep scales, adverse events, and need for follow-up open label injection. Results: Eight subjects were excluding after the initial PSG prior to randomization (six for lack of bruxism on PSG and two declined to continue). Twenty-three (19 female, age 47.4(16.9) were randomized. Almost all reported temporal-mandibular pain. All 13 randomized to drug and 9/10 randomized to placebo completed the study. CGI (p Conclusions: BoNT effectively and safely improved nocturnal bruxism in this small pilot trial. Multi-center confirmatory trials are justified. Supported by: Unrestricted grant from Allergan. Disclosure: Dr. Ondo has received personal compensation for activities with GlaxoSmithKline, Inc., Teva Neuroscience, Allergan, Inc., Merz Pharma, Ipsen, and Lundbeck Research USA, Inc. Dr. Ondo has received research support from GlaxoSmithKline, Inc., Bayer Healthcare, Takeda Pharmaceutical Company Limited, Teva Neuroscience, ACADIA, Parkinson Study Group and Huntington Study Group. Dr. Hashem has nothing to disclose. Dr. Hunter has received personal compensation for activities with Lundbeck Research USA, Inc. as a consultant. Dr. Simmons has received personal compensation for activities with Cephalon as a speaker.