At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
GSK1358820 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Lower limb spasticity ≥6 months post-stroke with equinus deformity (plantar flexion of the ankle)
- ✓MAS (Modified Ashworth Scale) ankle score ≥3
- ✓Age 20–80 years
- ✓Body weight ≥50 kg
Key exclusion· 14
- ✕Bilateral hemiplegia or quadriplegia
- ✕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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GSK1358820 and Placebo for Post-Stroke Spasticity and Cerebrovascular Accident. Completed, enrolled 120 participants across 20 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Stroke Spasticity, Cerebrovascular Accident
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartMay 2007
Primary CompletionDec 2008
TodayJul 2026
First PostedApr 16, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.2 years ago
Interventions
GSK1358820drug
botulinum toxin type A
Placebodrug
Placebo