Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients "Botox/Rehab"


Phase 0 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female, 18 to 70 years of age
- Written informed consent
- Written Authorization for Use and Release of Health and Research Study Information has been obtained
- Medically stable condition in the investigator's opinion
- History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers
- EMG evidence of volitionary activiation of wrist and finger extensor and flexor muscles
- Active range of motion (to be repeated 3 times by the patient): The ability to initiate wrist extension of at least 10 degrees from a fully flexed position with the forearm supported and stabilized in a pronated position. Active shoulder flexion and abduction to 45 degrees and no less than -30 degrees of elbow extension.
- Mini-Mental State Exam (MMSE) >24
- If on an anti-spasticity medication regiment at the time of qualification, the dose regimen must have been stable 1 month prior to study enrollment
- Ability to follow study instructions and likely to complete all required visits

Exclusion Criteria

- Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months
- Previous therapy with BOTOX® or any other botulinum toxin serotype for any condition within the last 12 months
- Phenol or alcohol block in the study limb within 6 months of study enrollment visit
- History (within 3 months of qualification) of or planned (during study period) casting of the study limb
- Current treatment with an intrathecal baclofen pump
- In the opinion of the investigator, profound atrophy of the muscles in the study limb that are targeted for injection
- Previous surgical intervention in the study limb, except for routine orthopedic repair for bone fractures, in the last 6 months
- Presence of fixed contracture of the study limb impairing functional activity
- Clinically significant inflammation or condition in the study limb that, in the investigator's opinion, could limit joint movement (other than stroke or spasticity)
- Clinically significant spasticity or contracture of the elbow (defined as an Ashworth score >3) or shoulder in the study limb, in the investigator's opinion would limit sue of the wrist and fingers
- Changes in oral spasticity medications within 30 days of enrollment (dose of anti-spasticity medications should remain the same during the study)
- Anticipated use of oral coagulants during the study
- Known allergy or sensitivity to the study medication or its components
- Infection or dermatological condition at anticipated injection sites
- Current participation in another clinical study or within 1 month of the enrollment visit
- Females who are pregnant, nursing, or planning a pregnancy during the study, or females of childbearing potential, not using a reliable means of contraception
- Anticipated use during the study of concurrent therapies for treatment of upper motor neuron syndrome (eg, acupuncture)
- Any medical condition that may put the patient 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
- Patient has a condition or is in a situation which in investigator's opinion may put the patient significant risk, may confound the study results, or may interfere significantly with patient's participation in the study