Botox vs. Baclofen for Upper Limb Spasticity

Inclusion Criteria: Outpatient, male or female subjects of any race, and at least 18 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 50mlU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study; Minimal 4-month history stable neurological disorder resulting focal upper limb muscle spasticity (wrist and/or elbow) Disability Assessment Scale (DAS) ≥ 2 for the principal therapeutic intervention target as chosen by Investigator and Subject (i.e., hygiene, dressing, pain and cosmesis). Subjects who are able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Exclusion Criteria: Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and are not practicing a reliable method of birth control. Severe contracture at the wrist or a history of tendon transfer in the study limb. Cast of study limb within four weeks of Visit 1. Profound atrophy of the muscles in the target area(s) of injection. Progressive neurological disorder (e.g., multiple sclerosis). Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function. Orthostatic hypotension or current use of alpha-2 adrenergic agonists (e.g. clonidine). Current anticoagulant therapy and INR > 3.5 Significantly impaired renal and/or hepatic function, in the opinion of the Investigator. Failure to meet prohibited concomitant medication criteria (Supplement I) Subjects planning inpatient surgery during the study. Any uncontrolled systemic disease. Allergy or sensitivity to any component of the study medication. Recent alcohol or drug abuse. History of poor cooperation, non-compliance with medical treatment, or unreliability. Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.