A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare
Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of
treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb
spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will
receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity
is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core
phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after
initial injection. During the extension phase, subjects will accept two follow-up visit (6
weeks). Outcome measures include changes from baseline at every post injection visit as
measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global
Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6
for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters
will also be measured including adverse events, vital signs (pulse and blood pressure) and
clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Phase:
Phase 3
Details
Lead Sponsor:
Lanzhou Institute of Biological Products Co., Ltd
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA