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Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
This study is ongoing, but not recruiting participants.
Study NCT00460564   Information provided by GlaxoSmithKline
First Received: April 13, 2007   Last Updated: March 10, 2008   History of Changes

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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP