Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
Condition: Post-Stroke Spasticity; Cerebrovascular Accident
MeSH terms: Muscle Spasticity; Stroke
Intervention: GSK1358820; Placebo
Intervention description: botulinum toxin type A; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Post-Stroke; Lower Limb; botulinum toxin type A; Spasticity

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.
    

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).