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