Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity

Exclusion Criteria

• •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •Bilateral hemiplegia or quadriplegia.
• •Presence of fixed contractures of the ankle (absence of range of motion).
• •Profound atrophy of the muscles to be injected.
• •Previous surgical intervention, phenol block, ethanol block, or Muscle Afferent Block (MAB) for ankle spasticity.
• •Casting of the study lower limb within 3 months prior to the start of double-blind phase (Visit 2).
• •Current treatment with intrathecal baclofen.
• •Use of peripheral muscle relaxants (dantrolene sodium, suxamethonium chloride, pancuronium bromide, vecuronium bromide, rocuronium bromide).
• •Concurrent use of antibiotics that interfere with neuromuscular transmission, such as aminoglycoside antibiotics (e.g., streptomycin sulfate, kanamycin sulfate, gentamicin sulfate, neomycin sulphate, spectinomycin hydrochloride), polypeptide antibiotics (e.g., polymixin B sulfate), lincomycin antibiotics (e.g., lincomycin hydrochloride, clindamycin), and enviomycin sulfate.
• •Previous or current botulinum toxin therapy of any serotype.
• •Diagnosis of systemic neuromuscular disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis).
• •Females who are pregnant, nursing, may be pregnant, or planning a pregnancy during the study period.
• •Known allergy or hypersensitivity to any ingredient of study medication (e.g., human serum albumin).
• •Presence of psychiatric disorder or impairment of intellectual function that may interfere with the subject's ability to give informed consent or the conduct of the study.
• •Bedridden patients.
• •Presence of clinically unstable severe cardiovascular disease.
• •Presence of clinically significant severe renal or hepatic disease.
• •Infection or dermatological condition at the proposed injection sites.
• •Previous or planned participation in another clinical study (including the upper limb spasticity study of GSK1358820) within 6 months prior to the start of double-blind phase (Visit 2).
• •Clinically significant severe reduction of muscle strength.
• •Angle closure glaucoma or its preposition (narrow angle).