Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Botulinum Toxin Type A · 2 trials · 2 indications
The investigator or assessor 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 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
| Arm | Type | Description |
|---|---|---|
| BTX-A | EXPERIMENTAL | Botulinum toxin type A |
| A | EXPERIMENTAL | Injection |
| B | PLACEBO_COMPARATOR | Injection |
| Name | Type | Description |
|---|---|---|
| Botulinum toxin type A | DRUG | Botulinum toxin type A |
| sodium chloride | DRUG | sodium chloride 0.9 mg |
Inclusion Criteria: 1. Within 3 months after completion of the GSK/Allergan study 112958. 2. Wrist flexor muscle tone of 2 or greater and finger flexor muscle tone of 1 or greater as measured on MAS (0 to 4). 3. At least one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) wi...
Botulinum Toxin Type A is used for glabellar lines, also known as frown lines, and for the treatment of post-stroke focal upper limb spasticity. It is being developed by GSK plc for these dermatological and neurological conditions.
Botulinum Toxin Type A is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The drug is currently in Phase 3 clinical development for its approved indications.
Botulinum Toxin Type A is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials have been completed, with a total of 365 participants enrolled across two studies.
Botulinum Toxin Type A has been studied in two completed Phase 3 trials. The first, NCT00408785, evaluated the drug for glabellar lines in 256 participants in China. The second, NCT01205451, assessed its safety and efficacy in 109 Chinese subjects with post-stroke focal upper limb spasticity.
Botulinum Toxin Type A is the active ingredient in BOTOX, a brand name for the drug. The clinical trial NCT00408785 specifically refers to the treatment of glabellar lines with BOTOX, indicating that Botulinum Toxin Type A and BOTOX are the same medication.