Phase 3
N=120
Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
Post-Stroke Spasticity · Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT00460655 ↗Enrolled (actual)
120
Serious AEs
7.5%
Results posted
Jan 2010
Primary outcome: Primary: 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) — -8.513; -5.085 Score*week — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK1358820 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-8.513; -5.085 | 0.006 sig |
| SECONDARY Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase |
-0.61; -0.52; -0.88; -0.43; -0.91; -0.47 | — |
| SECONDARY Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase |
0.40; 0.66; 0.54; 0.63; 0.46; 0.72 | — |
| SECONDARY Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase |
2.14; -5.02; -6.10; -7.37; -7.80; -8.48 | — |
| SECONDARY 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 |
0.82; 0.45; 1.09; 0.64; 1.21; 0.66 | — |
| SECONDARY 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 |
0.49; 0.34; 0.75; 0.44; 0.82; 0.72 | — |
| SECONDARY Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase |
0.63; 0.48; 0.64; 1.07; 0.82; 1.03 | — |
| SECONDARY Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase |
-1.37; -1.27; -1.29; -1.33; -1.03; -1.04 | — |
| SECONDARY Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase |
1.10; 1.35; 1.17; 1.46; 0.91; 1.15 | — |
| SECONDARY Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase |
-11.21; -12.09; -11.14; -8.05; -10.50; -9.29 | — |
| SECONDARY Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase |
1.43; 1.43; 1.40; 1.54; 1.11; 1.21 | — |
| SECONDARY Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase |
0.92; 1.00; 0.98; 1.04; 0.66; 1.19 | — |
| SECONDARY Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase |
1.14; 1.54; 1.40; 1.54; 1.28; 1.46 | — |
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.
Eligibility 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 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.
- 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.
- Clinically significant severe reduction of muscle strength.
- Angle closure glaucoma or its preposition (narrow angle).
Data sourced from ClinicalTrials.gov (NCT00460655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.