A new botulinum toxin type A free of complexing proteins (NT 201) was compared with BOTOX in patients with cervical dystonia by means of a double-blind noninferiority trial. Four hundred sixty-three patients received IM injections of 70 to 300 U of NT 201 or BOTOX and were followed up over 16 weeks. The study clearly shows that NT 201 is at least as effective and safe as BOTOX.
NT 201 is a new development of Botulinum Toxin Type A free of complexing proteins. In this double-blind Phase III trial, we compared the efficacy and safety of NT 201 and BOTOX in patients suffering from blepharospasm. Of 304 enrolled patients, 300 patients received study medication (intent-to-treat population), and 256 patients completed the study as planned (per-protocol population). At baseline, patients received a single injection of NT 201 or BOTOX (
NT 201 led to statistically significant improvements in muscle tone and disability and was well tolerated in patients with poststroke upper limb spasticity.
The objective was to analyze the metric properties of the Jankovic Rating Scale (JRS) and a self-rating patient response outcome scale, the Blepharospasm Disability Index (BSDI), in blepharospasm patients. Data from a randomized, double-blind, active-control clinical trial in 300 patients with blepharospasm treated with either botulinum toxin type A (Botox) or NT201 (Xeomin) were used to evaluate the metric properties of the JRS and the BSDI compared with the Patient Evaluation of Global Response (PEGR) and Global Assessment Scale (GAS). The internal consistency of the BSDI was high, Cronbach's Alpha = 0.88, and the retest reliability of the BSDI single items was adequate, Spearman's rank coefficient = 0.453 < r < 0.595. The correlation between JRS sum score and BSDI weighted mean score was r = 0.487 (baseline) and r = 0.737 (control visit), respectively. Using the GAS and PEGR, the results suggest that a change of 2 points in the JRS and of 0.7 points in the BSDI are clinically meaningful. JRS and BSDI are objective indicators of clinical efficacy as suggested by their good validity when compared with physicians' and patients' rating scales. Both, JRS and BSDI, can be used to reliably assess blepharospasm in treatment trials.
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