Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity

NCT00460655 | Completed Phase 3 Results

• 1 other identifier: BTX108512
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Post-Stroke Spasticity; Cerebrovascular Accident

Keywords

Post-Stroke; Lower Limb; botulinum toxin type A; Spasticity

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12)

  Change from baseline in MAS ankle score using a 6-point scale (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.

  Baseline, Week 12

Secondary Outcomes (12)

• Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase

  Baseline; Weeks 1, 4, 6, 8, and 12

• Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase

  Baseline; Weeks 1, 4, 6, 8, and 12

• Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase

  Baseline; Weeks 1, 4, 6, 8, and 12

• Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase

  Baseline; Weeks 1, 4, 6, 8, and 12

• Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase

  Baseline; Weeks 1, 4, 6, 8, and 12

Study Arms (2)

BTX

ACTIVE COMPARATOR

Drug: GSK1358820

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GSK1358820 DRUG

botulinum toxin type A

BTX

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 Muscle Afferent Block (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, rocuronium 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Fukuoka, 811-0213, Japan

Location

GSK Investigational Site

Hiroshima, 720-0825, Japan

Location

GSK Investigational Site

Hiroshima, 728-0001, Japan

Location

GSK Investigational Site

Hokkaido, 005-0802, Japan

Location

GSK Investigational Site

Hokkaido, 005-8555, Japan

Location

GSK Investigational Site

Hokkaido, 006-0805, Japan

Location

GSK Investigational Site

Hokkaido, 053-0803, Japan

Location

GSK Investigational Site

Ibaraki, 302-0112, Japan

Location

GSK Investigational Site

Kanagawa, 227-8518, Japan

Location

GSK Investigational Site

Kanagawa, 247-8533, Japan

Location

GSK Investigational Site

Kanagawa, 253-8558, Japan

Location

GSK Investigational Site

Kanagawa, 257-0001, Japan

Location

GSK Investigational Site

Kumamoto, 860-8518, Japan

Location

GSK Investigational Site

Shizuoka, 410-1128, Japan

Location

GSK Investigational Site

Shizuoka, 410-2507, Japan

Location

GSK Investigational Site

Shizuoka, 410-3293, Japan

Location

GSK Investigational Site

Tokyo, 105-8471, Japan

Location

GSK Investigational Site

Tokyo, 140-0001, Japan

Location

GSK Investigational Site

Tokyo, 142-8666, Japan

Location

GSK Investigational Site

Yamaguchi, 740-0021, Japan

Location

Related Publications (1)

• Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M; GSK1358820 Spasticity Study Group. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol. 2010 Aug;257(8):1330-7. doi: 10.1007/s00415-010-5526-3. Epub 2010 Apr 1.

  PMID: 20358216 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 8, 2010
• Results First Posted: January 26, 2010

Record last verified: 2010-08

Locations

JP (20)