Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02280083 | A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity | PHASE3 | COMPLETED | 180 | — | — | Jul 1, 2014 | Sep 1, 2016 | Sep 26, 2016 | - | — |
The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.
| Arm | Type | Description |
|---|---|---|
| Botulinum Toxin Type A for Injection | EXPERIMENTAL | HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®") |
| placebo | PLACEBO_COMPARATOR | excipient |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxin Type A for Injection | DRUG | HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®") |
| placebo | DRUG | placebo |
Inclusion Criteria: * ≥40kg in weight. * Subjects voluntarily sign the informed consent. * Subjects with upper limb spasticity who are at least 3 months post stroke and present with spasticity of both the wrist and fingers in the study limb. * Both wrist flexor muscle tone and finger flexor muscle ...