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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03261167 | A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity | PHASE3 | COMPLETED | 124 | — | — | Aug 2, 2017 | Jan 10, 2019 | Jun 2, 2020 | 38 | Japan |
MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.
| Arm | Type | Description |
|---|---|---|
| Part 1: Subjects receiving 400 units of botulinum toxin A | EXPERIMENTAL | Subjects will receive a total dose of 400 units of botulinum toxin A of which 240 units will be injected into the muscles that act on finger (including thumb flexors) and wrist flexors, and a total of 160 units will be injected into the muscles that act on the elbow flexors. |
| Part 1: Subjects receiving 240 units of botulinum toxin A | ACTIVE_COMPARATOR | Subjects will receive 240 units of botulinum toxin A injected into the muscles that act on the finger (including thumb flexors) and wrist flexors. Placebo will be injected into the muscles that act on the elbow flexors. |
| Part 2,3,4: Subjects receiving 400 units of botulinum toxin A | EXPERIMENTAL | Subjects will receive botulinum toxin A with a dose of 400 units injected in a divided doses. |
| Name | Type | Description |
|---|---|---|
| Botulinum toxin A (GSK1358820) | DRUG | GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams \[mg\]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units. |
| Placebo | DRUG | Placebo injection will contain sodium chloride (0.9 mg). |
Inclusion Criteria: * For screening phase (Day -28 to Day -1): Between 20 and 80 years of age at the time of informed consent (ICF). * Subjects with at least a 3-month history of upper limb spasticity after the most recent stroke. * Subjects who have spastic symptoms in the finger (including the th...