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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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).