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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Cerebrovascular Accident

Post-Stroke Spasticity

Treatments

Drug: GSK1358820

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00460655

BTX108512

Details and patient eligibility

About

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.

Full description

Enrollment

120 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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).