A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: placebo
    Description: excipient
  • Botulinum Toxin Type A for Injection Drug
    Other Names: HengLi®
    Intervention Desc: HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®")
    ARM 1: Kind: Experimental
    Label: Botulinum Toxin Type A for Injection
    Description: HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®")

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change From Baseline at Week 6 of Wrist Flexor Muscle Tone is calculated by the Modified Ashworth Scale (MAS) Baseline (Day 0) and Week 6 Yes
Secondary Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score Baseline (Day 0), Week 6, and Week 12 No
Secondary Change From Baseline at Weeks 1, 4, 8, 12, 16 and 18 for Wrist Flexor Muscle Tone are calculated by the MAS Baseline (Day 0) and Weeks 1, 4, 8, 12, 16 and 18 No
Secondary Proportion of subjects Classified as Wrist Treatment Responders at All Post-injection Visits Weeks 1, 4, 6, 8, 12, 16 and 18 No
Secondary Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of Finger Flexor Muscle Tone are calculated by the MAS Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18 No
Secondary Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of Thumb Flexor Muscle Tone are calculated by the MAS Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18 No
Secondary Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of individual situations are calculated by the Disability Assessment Scale (DAS) Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18 No
Secondary Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points Weeks 1, 4, 6, 8, 12, 16 and 18 No
Secondary GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points Weeks 1, 4, 6, 8, 12, 16 and 18 No
Secondary Change From Baseline at Weeks 1, 4, 8, 12, 16 and 18 for Wrist Flexor Muscle Tone are calculated by the MAS Baseline (Day 0) and Weeks 1, 4, 8, 12, 16 and 18 No

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