Study 19 of 108 for search of: Spasticity
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Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00460564
  Purpose

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.


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, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 105
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:

    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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460564

Locations
Japan
GSK Clinical Trials Call Center
Miyoshi City, Japan, 728
GSK Clinical Trials Call Center
Tomakomai City, Japan, 053
GSK Clinical Trials Call Center
Sapporo City, Japan, 005
GSK Clinical Trials Call Center
Moriya City, Japan, 360
GSK Clinical Trials Call Center
Iwakuni City, Japan, 740
GSK Clinical Trials Call Center
Susono City, Japan, 410
GSK Clinical Trials Call Center
Hadano City, Japan, 257
GSK Clinical Trials Call Center
Sapporo City, Japan, 006
GSK Clinical Trials Call Center
Chigasaki City, Japan, 253
GSK Clinical Trials Call Center
Kumamoto City, Japan, 860
GSK Clinical Trials Call Center
Fukuyama City, Japan, 720
GSK Clinical Trials Call Center
Izu City, Japan, 410
GSK Clinical Trials Call Center
Yokohama City, Japan, 227
GSK Clinical Trials Call Center
Tokyo, Japan, 142
GSK Clinical Trials Call Center
Tokyo, Japan, 105
GSK Clinical Trials Call Center
Kamakura City, Japan, 247
GSK Clinical Trials Call Center
Fukuoka City, Japan, 811
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Study ID Numbers: BTX108509
Study First Received: April 13, 2007
Last Updated: March 10, 2008
ClinicalTrials.gov Identifier: NCT00460564  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Post-Stroke
Spasticity
Upper 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