Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity

Inclusion Criteria:

• Adults 18 years of age or older
• Stroke (ischemic or hemorrhagic) diagnosed by a neurologist at least 6 months prior to enrollment
• Focal spasticity in upper limb measured at the elbow, wrist, fingers and thumb with a Modified Ashworth Scale (MAS) of 3 or greater in the wrist and/or fingers
• Functional impairment secondary to spasticity such as difficulty with hygiene, dressing, posture or pain
• Minimum weight of 44 kg (88 lbs) in order to tolerate the minimum required dosage of 200 U
• Written informed consent has been obtained
• Written authorization for Use and Release of Health and Research Study Information has been obtained
• Laboratory findings required (if applicable)
• Ability to follow study instructions and likely to complete all required visits
• Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential). (If applicable.)

Exclusion Criteria:

• Uncontrolled clinically significant medical condition other than the condition under evaluation
• Known allergy or sensitivity to any of the components in the study medication
• Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
• Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment
• Fixed contracture or profound atrophy in the spastic limb
• Prior or current treatment with neurolytic agents such as phenol or surgery; any version of botulinum toxin (other than BoNT-A more than 6 months prior to enrollment)
• Current rehabilitation therapy that cannot be altered to the treatment plan in the study
• Unable or unwilling to participate in a weekly rehab program
• Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
• Current treatment with agents affecting neuromuscular transmission
• Evidence of recent alcohol or drug abuse
• Infection or skin disorder at an anticipated injection site (if applicable)
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study