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Also known as Botulinum toxin A (GSK1358820)
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 being developed for the treatment of spasticity following a stroke, specifically post-stroke upper limb spasticity. It is an investigational therapy in Phase 3 clinical development. The condition involves increased muscle stiffness in the arms after a stroke, and the drug is being studied to evaluate its efficacy and safety in this patient population.
Botulinum toxin A targets SNAP25, a protein involved in the release of neurotransmitters from nerve cells. By acting on SNAP25, the drug is designed to inhibit the release of acetylcholine at the neuromuscular junction, which can reduce muscle overactivity. This mechanism underlies its development for conditions characterized by excessive muscle contraction, such as post-stroke spasticity.
Botulinum toxin A is being developed by GSK plc, which trades under the ticker GSK. GSK is conducting clinical development of the drug, including a Phase 3 study in post-stroke upper limb spasticity. The company is responsible for the investigational program for this asset.
Botulinum toxin A is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities for the studied indication. The Phase 3 trial has been completed, and the drug remains under evaluation for post-stroke upper limb spasticity.
Botulinum toxin A has been studied in a Phase 3 clinical trial, NCT03261167, titled "A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity." This completed trial enrolled 124 participants in Japan and was randomized, double-blind, and active-controlled.
Yes, Botulinum toxin A is also known as GSK1358820. GSK1358820 is the development code used by GSK plc for this investigational botulinum toxin A product. Both names refer to the same asset being studied in post-stroke upper limb spasticity.