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Merz Pharmaceuticals Announces Phase III Data for NT 201 in Post-stroke Upper Limb Spasticity
Date:10/6/2009

gatively impact mobility, ability to carry out personal hygiene, and other activities of daily living. In this study, significant improvements were shown in each of the four domains of the Disability Assessment Scale (DAS), including dressing, limb position, hygiene and pain, among patients treated with NT 201.

About Phase III Study

The Phase III study, conducted at 23 sites in Europe, included patients who, at least 6 months prior to enrollment, had experienced a stroke resulting in focal spasticity of the wrist and finger flexors (scores of greater than or equal to 2 on the Ashworth Scale). Participants were required also to have DAS scores of 2 or higher (at least moderate disability) in their chosen therapeutic target domain: dressing, limb position, hygiene or pain.

Medications to treat spasticity such as centrally-acting muscle relaxants and/or benzodiazepines and physical and occupational therapy regimens were permitted if they had been stable in the 2 weeks before screening, but no treatment changes were allowed during the study.

While treatment of the wrist and finger muscles was mandatory, other spastic upper limb muscle groups were treated as individually needed according to the investigator's clinical judgment. The maximum intended dose of study medication was 400 U. Follow-up was for up to 20 weeks.

In an intention-to-treat analysis among a total of 148 patients (NT 201=73; placebo=75), a larger proportion of NT 201 patients (mean 63.9%) were rated as responsive in each of five treatment muscle groups at week 4 as compared with patients receiving placebo (mean 35.72%). For the primary endpoint of wrist flexor treatment, the odds ratio (OR) of 3.97 favored NT 201 treatment significantly (95% confidence interval, 1.9-8.3; P <0.001). Significant ORs in favor of NT 201 ranging from 3.16 to 13.43 (P< 0.009) were observed for all other flexor muscle groups at week 4. Statistically
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SOURCE Merz Pharmaceuticals
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