| April 13, 2007 |
| March 10, 2008 |
| May 2007 |
| December 2008 (final data collection date for primary outcome measure) |
- Change in MAS wrist score
- Change from baseline in MAS wrist score
- Change from baseline in DAS score
- Global impression of therapeutic benefit of GSK1358820 to rehabilitation if any change is made to permissible concomitant rehabilitation therapy during the open-label phase.
|
| Same as current |
| Complete list of historical versions of study NCT00460564 on ClinicalTrials.gov Archive Site |
- Efficacy:
MAS, Disability Assessment Scale (DAS), Clinical Global Impression (CGI)
Safety:
Adverse events, clinical laboratory tests, pulse rate, blood pressure, 12-lead ECG, pulmonary function tests
- An area under the curve (AUC) based on the change from baseline in MAS wrist score in the low dose groups during the double-blind phase.
- Change from baseline in MAS finger score
- Change from baseline in CGI of functional disability
|
- Efficacy:
- MAS, Disability Assessment Scale (DAS), Clinical Global Impression (CGI)
- Safety:
- Adverse events, clinical laboratory tests, pulse rate, blood pressure, 12-lead ECG, pulmonary function tests
|
| |
| Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity |
| A Multicenter Study to Evaluate the Efficacy and Safety in Patients With Post-Stroke Upper 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 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Post-Stroke Spasticity |
| Drug: GSK1358820 |
| |
| |
| |
| Active, not recruiting |
| 105 |
| 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:
1) 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 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).
- 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.
|
| Both |
| 20 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| NCT00460564 |
|
| BTX108509 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| March 2008 |