April 13, 2007 |
October 9, 2008 |
May 2007 |
Change in MAS ankle score |
Same as current |
Complete list of historical versions of study NCT00460655 on ClinicalTrials.gov Archive Site |
- Efficacy:
MAS, Physician's Rating Scale (PRS), speed of gait, Clinical Global Impression (CGI)
Safety:
Adverse events, clinical laboratory tests, pulse rate, blood pressure, 12-lead ECG
- Change from baseline in the MAS ankle score
- Change from baseline in speed of gait
- Global impression of therapeutic benefit of GSK1358820 to rehabilitation if any change is made to permissible concomitant rehabilitation therapy during
the open-label phase.
- Change from baseline in PRS score
- Change from baseline in CGI score
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- Efficacy:
- MAS, Physician's Rating Scale (PRS), speed of gait, Clinical Global Impression (CGI)
- Safety:
- Adverse events, clinical laboratory tests, pulse rate, blood pressure, 12-lead ECG
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Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity |
A Multicenter Study to Evaluate the Efficacy and Safety in Patients With Post-Stroke Lower Limb Spasticity Receiving a Double-Blind, Placebo-Controlled GSK1358820 Treatment Followed by an Open-Label GSK1358820 Treatment |
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. |
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Phase III |
Interventional |
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Post-Stroke Spasticity |
Drug: GSK1358820 |
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Active, not recruiting |
120 |
December 2008 |
December 2008 (final data collection date for primary outcome measure) |
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 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).
- 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.
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Both |
20 Years to 80 Years |
No |
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Japan |
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NCT00460655 |
Study Director, GSK |
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GlaxoSmithKline |
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Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
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GlaxoSmithKline |
October 2008 |