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Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
This study is ongoing, but not recruiting participants.
Study NCT00460655   Information provided by GlaxoSmithKline
First Received: April 13, 2007   Last Updated: October 9, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

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
  • 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
 
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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, 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
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.
Both
20 Years to 80 Years
No
 
Japan
 
 
NCT00460655
Study Director, GSK
 
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.