Study Of GSK1358820 In Patients With Post-Stroke Upper 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

NCT00460564

BTX108509

Details and patient eligibility

About

This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.

Full description

This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.

Enrollment: 109 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 upper limb spasticity who are at least 6 months post stroke and present with spasticity of both the wrist and fingers at the start of double-blind phase (Visit 2).
• Wrist flexor muscle tone of ≥3 and finger flexor muscle tone of ≥2 on the MAS, and at least one functional disability item (i.e., hygiene, pain, dressing or limb posture) with a rating of ≥2 on the Disabilty Assessment Scale (DAS) 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.
• ≥40kg 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.
• 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 wrist and/or fingers (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 wrist and/or finger spasticity.
• Casting of the study upper 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 botulinum toxin therapy.
• 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, hepatic or respiratory disease.
• Infection or dermatological condition at the proposed injection sites.
• Previous or planned participation in another clinical study (including the lower 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 4 patient groups, including a placebo group

High-Dose BTX

Active Comparator group

Treatment:

Drug: GSK1358820

High-Dose Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Low-Dose BTX

Active Comparator group

Treatment:

Drug: GSK1358820

Low-Dose Placebo

Active Comparator group

Treatment:

Drug: Placebo