study of gsk1358820 in patients with post-stroke lower limb spasticity

Conditions: Post-Stroke Spasticity; Cerebrovascular Accident

Summary: this is a study to confirm the superior efficacy of gsk1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the modified ashworth scale (mas) ankle score.

this is a study to confirm the superior efficacy of gsk1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the modified ashworth scale (mas) ankle score.

Eligibility criteria:
inclusion criteria: * subjects eligible for enrollment in the study must meet all of the following criteria: * patients with lower limb spasticity who are at least 6 months post-stroke and present with equinus deformity (plantar flexion of the ankle) at the start of double-blind phase (visit 2). * patients with mas ankle score of ≥3 at the start of double-blind phase (visit 2). * male or female between 20 and 80 years of age at the time of informed consent. for males, only those who can practice contraception during the study period are eligible. * ≥50kg in weight at the start of double-blind phase (visit 2). * inpatient or outpatient; however, the hospitalization status must remain unchanged during the double-blind phase. note: subjects may be hospitalized for ≤10 days after injection during the treatment period. * written informed consent from the subject him/herself. if the subject's signature is not legible, the attendance of a witness is required. 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). * others whom the investigator or sub investigator considers not eligible for the study. * clinically significant severe reduction of muscle strength. * angle closure glaucoma or its preposition (narrow angle).

Keywords: post-stroke lower limb botulinum toxin type a spasticity