Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

Status:	Completed
Conditions:	Neurology
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - 80
Updated:	4/21/2016
Start Date:	September 2011
End Date:	February 2014

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

The purpose of this study is to determine whether injections of Botulinum toxin type A into
muscles of the upper limb are effective in treating spasticity in patients after stroke.

The study consists of a randomized, double-blind, placebo-controlled, parallel-group,
single-dose main period followed by an open-label, non-controlled, repeated-dose extension
period (Open-Label Extension Period - OLEX).

Inclusion Criteria:

- Upper limb spasticity

- Time since stroke greater than 3 months

- Need for 400 U Botulinum toxin type A

Exclusion Criteria:

- Body weight below 50kg

- Fixed contractures of the upper limb

- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of
Botulinum toxin Type A

- Infection at the injection site

We found this trial at

sites

Merz Investigational Site #001198

Stratford, New Jersey 08084

from

Stratford, NJ