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Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting
Date:6/8/2009

t-Batar, A., and Minnasch, P.

Method

Responder analysis of at least 1-point improvement from baseline to week 4 on the Disability Assessment Scale [DAS] for the primary therapeutic target after injection of a 20 U/mL dilution or 50 U/mL dilution was evaluated. After injection, observation over a 12-week period was followed by 8 weeks safety follow-up. Botulinum neurotoxin doses were derived from the recommendations from the organization WE MOVE. The individual injection pattern was adapted to patient's needs. A two-sided 95% Newcombe-Wilson confidence interval [CI] for the difference between groups was calculated.

Results

192 patients with upper limb spasticity caused by either stroke (88%), brain injury (5.7%), multiple sclerosis (0.5%) or cerebral palsy (1.6%) were randomized to the 50 U/mL dilution group (95 patients) or to the 20 U/mL dilution group (97 patients). Limb position (60.4%), Dressing (24.0%), Hygiene (9.4%) and Pain (6.3%) were chosen as primary therapeutic target on the DAS. The maximum injected total dose was 495 units NT 201. Four weeks after injection 57.1% of patients had an at least 1-point DAS reduction from the baseline score for their primary therapeutic target. No dilution group was inferior to each other regarding efficacy. 79.9% of patients and 89.0% of investigators reported an improvement in global assessment of efficacy at week 4. There were no relevant differences regarding safety between groups.

About Merz

Merz (KGAa) is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in research and development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic dermatology, including products for the treatment of wrinkles and aging skin, hair loss and acne. Research is concentrated in fi
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