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Botulinum toxin A · 1 trial · 1 indication
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...
Botulinum toxin A is used for post-stroke spasticity, specifically upper limb spasticity that occurs after a stroke. It is being studied as a treatment to reduce muscle stiffness and improve function in affected patients. The drug is currently in Phase 3 clinical development for this indication.
Botulinum toxin A targets the neuromuscular junction, where it blocks the release of acetylcholine from nerve endings. This action reduces muscle overactivity and spasticity, which is the basis for its use in treating post-stroke upper limb spasticity. The drug is administered locally to affected muscles.
Botulinum toxin A is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of post-stroke spasticity.
Botulinum toxin A is in Phase 3 clinical development for post-stroke spasticity. The drug is investigational and has not yet been approved by regulatory authorities. A Phase 3 study has been completed, and the results will inform potential regulatory submissions.
Botulinum toxin A has one completed Phase 3 trial, NCT03261167, titled 'A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity.' This randomized, double-blind, active-controlled study enrolled 124 participants in Japan and evaluated the drug's effects on upper limb spasticity.
Yes, Botulinum toxin A is also known as GSK1358820. The Phase 3 clinical trial NCT03261167 uses the name GSK1358820 to refer to the drug. Both names refer to the same investigational treatment for post-stroke upper limb spasticity.