Study 18 of 108 for search of: Spasticity
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Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00460655
  Purpose

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.


Condition Intervention Phase
Post-Stroke Spasticity
Drug: GSK1358820
Phase III

Drug Information available for: Clostridium botulinum toxin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in MAS ankle score

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: May 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460655

Locations
Japan
GSK Investigational Site
Tokyo, Japan, 105-8461
GSK Investigational Site
Shizuoka, Japan, 410-3293
GSK Investigational Site
Kanagawa, Japan, 257-0001
GSK Investigational Site
Hiroshima, Japan, 720-0825
GSK Investigational Site
Kanagawa, Japan, 253-8558
GSK Investigational Site
Hokkaido, Japan, 005-8555
GSK Investigational Site
Kanagawa, Japan, 247-8533
GSK Investigational Site
Kumamoto, Japan, 860-8518
GSK Investigational Site
Ibaraki, Japan, 302-0112
GSK Investigational Site
Hiroshima, Japan, 728-0001
GSK Investigational Site
Kanagawa, Japan, 227-8518
GSK Investigational Site
Shizuoka, Japan, 410-2507
GSK Investigational Site
Shizuoka, Japan, 410-1128
GSK Investigational Site
Fukuoka, Japan, 811-0213
GSK Investigational Site
Hokkaido, Japan, 006-0805
GSK Investigational Site
Hokkaido, Japan, 005-0802
GSK Investigational Site
Hokkaido, Japan, 053-0803
GSK Investigational Site
Yamaguchi, Japan, 740-0021
GSK Investigational Site
Tokyo, Japan, 142-8666
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: BTX108512
Study First Received: April 13, 2007
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00460655  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Post-Stroke
Spasticity
Lower Limb
botulinum toxin type A

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Muscle Spasticity
Botulinum Toxins
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Brain Ischemia
Neurologic Manifestations
Brain Infarction
Botulinum Toxin Type A
Infarction

Additional relevant MeSH terms:
Neuromuscular Manifestations
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 30, 2009