BOTB (BOTULINUM TOXIN TYPE-B), EVALUATION OF SAFETY AND TOLERABILITY IN BOTULINUM TOXIN TYPE A-RESISTANT CERVICAL DYSTONIA PATIENTS (PRELIMINARY-STUDY)

Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilo t, open-label, dose-escalation study with BTX type B in 12 patients wh o no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderat e adverse events generally resolved quickly and included asthenia, pai n, nausea, dysphagia, hypertonia, and tremor. No serious adverse event s or antibodies to type-B treatment were reported, Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto West e rn Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity) , Patient Analogue Pain Scale, and Physician and Patient Global Assess ment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 2 8.8% difference between the low-dose and high-dose groups, respectivel y. Effectiveness was noted for the high-dose group on the Patient Anal ogue Pain Scale but not on the Global Assessment Scales.