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


Phase N/A Results

Eligibility Criteria

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