Botox vs. Baclofen for Upper Limb Spasticity

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.