A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity
Condition: Cerebrovascular Accident
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      The primary purpose is to prove the efficacy of treatment administration with Botulinum Toxin
      Type A for Injection (HengLi®) beyond placebo in subjects with post-stroke upper limb
      spasticity of both wrist and fingers flexors as measured on the Modified Ashworth Scale
      (MAS).

      Subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if
      thumb spasticity is present) or placebo after they first enroll the core phase randomly.
      Totally 180 subjects will be recruited in this part. Each completed subject should finish 8
      (visit 0 to 7) clinic visits. Subjects will receive a single intramuscular treatment with
      either HengLi® or placebo at day 0 (visit 0). The else 7 visits are at week 1, 4, 6, 8, 12,
      16 and 18 (visits 1 to 7) and week 6 (visit 3) is appointed as the primary visit to determine
      efficacy.

      The primary endpoint is the change from baseline at week 6 for wrist flexor muscle tone as
      measured on the Modified Ashworth Scale (MAS). The secondary endpoints involve the area under
      curve (AUC) for the MAS wrist score change from baseline, change from baseline for
      wrist/finger/thumb flexor muscle tone as measured on MAS, DAS and GAS. The safety measures
      involve adverse events, clinical laboratory tests and pulse, blood pressure.
    

Intervention name(s): Botulinum Toxin Type A for Injection; placebo
Intervention type(s): Drug; Drug
Intervention description(s): HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®"); placebo
Other intervention name(s): HengLi®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spasticity, Post-Stroke; Botulinum toxin type A for Injection; upper limb spasticity