BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity

Exclusion Criteria

• •Female subjects who are pregnant (positive urine pregnancy test at Visit 1/screening), nursing, planning a pregnancy during the study period or female subjects of childbearing potential who are not using a reliable means of contraception. Reliable means of contraception. Reliable methods of contraception are hormonal methods or intrauterine device in use at least 14 days before study drug administration.
• •Subjects with a severe contracture at the wrist (inability to passively move the joint more than 10 degrees) or a history of tendon transfer in the study limb.
• •Subjects who have had a cast of the study limb within two weeks of the Visit 1/Screening or are planning casting of the study limb during the study period.
• •Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
• •Subjects with profound atrophy (as per the Investigator's assessment) of the muscle in the target area(s) of injection.
• •Subjects with an infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).
• •Subjects with diagnosed orthostatic hypotension or subjects that are taking alpha-2 adrenergic agonists (e.g. clonidine).
• •Subjects with impaired renal and/or hepatic function.
• •Subjects with a known allergy or sensitivity to the study medications or its components.
• •Subjects who are currently taking tizanidine or have taken tizandidine within 14 days prior to Visit 2/Baseline.
• •Subjects who have received previous botulinum toxin injection(s) of any serotype into the target limb within 4 months of Visit 2/Baseline.
• •Subjects who have received phenol or alcohol injections to the study limb.
• •Subjects who are currently taking oral gabaergic medications (baclofen, gabapentin, benzodiazepines) or dantrolone sodium, or have been taking these drugs within 2 weeks of baseline (Visit 2). Please note that benzodiazepines will be excluded only as antispasmodic medications but not as hypnotics or anxiolytics on a PRN basis.
• •Subjects who have not been on stable doses of their CNS medications (antidepressant, antianxiety drugs) for at least 2 months prior to Visit 1 (dose regimen must remain stable throughout the study).
• •Subjects who are currently using medication that are contraindicated with the concomitant use of BOTOX® or Zanaflex®.
• •Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of Visit 1/Screening.
• •Subjects that in the Investigator's opinion have a concurrent condition that may put them at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.
• •Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
• •Subjects currently receiving anticoagulant therapy and who have an INR \> 3.5