CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 109 enrolled
Drug / intervention
GSK1358820 +1 moredrug
Likely dose
GSK1358820 (botulinum toxin type A) — specific dose not stated in interventions or armsAI-extracted
Key inclusion· 5
  • ✓Patients with upper limb spasticity at least 6 months post-stroke presenting with spasticity of both wrist and fingers at Visit 2
  • ✓Wrist flexor muscle tone ≥3 and finger flexor muscle tone ≥2 on the Modified Ashworth Scale (MAS)
  • ✓At least one functional disability item (hygiene, pain, dressing, or limb posture) with a rating ≥2 on the Disability Assessment Scale (DAS)
  • ✓Age 20–80 years at the time of informed consent
Key exclusion· 14
  • ✕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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00460564
NCT00460564Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Apr 16, 2007·Updated May 30, 2017

In Brief

A Phase 3 clinical trial evaluating GSK1358820 and Placebo for Post-Stroke Spasticity and Cerebrovascular Accident. Completed, enrolled 109 participants across 18 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Stroke Spasticity, Cerebrovascular Accident
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
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