Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes

The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.

Inclusion Criteria:

• Upper and lower limb spasticity of the same body side due to cerebral causes
• Time since event leading to spasticity in the target body side greater than 12 weeks
• Need for 800 units Botulinum toxin type A

Exclusion Criteria:

• Body weight below 50kg
• Fixed contractures of the target joint
• Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
• Infection at the injection site