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Botulinum Toxin Type A 300U · 1 trial · 1 indication
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
| Arm | Type | Description |
|---|---|---|
| Botulinum Toxin Type A 300U | EXPERIMENTAL | Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Botulinum Toxin Type A 200U | EXPERIMENTAL | Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxin Type A 300U | BIOLOGICAL | Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Botulinum Toxin Type A 200U | BIOLOGICAL | Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
Inclusion Criteria: * Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled: * Patient completed at least 52 weeks in the preceding study. * No longer than 6 months has elapsed since completion of the preceding study * Patient has not received any pr...
Botulinum Toxin Type A 300U is used for overactive bladder, a condition characterized by a sudden urge to urinate. It is being developed as a treatment for patients with this condition, including those whose overactive bladder results from spinal injury or multiple sclerosis.
Botulinum Toxin Type A 300U is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
Botulinum Toxin Type A 300U is in Phase 3 clinical development for overactive bladder. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed.
Botulinum Toxin Type A 300U has one completed Phase 3 clinical trial, identified as NCT00876447. This was a long-term follow-up study in patients with overactive bladder resulting from spinal injury or multiple sclerosis, enrolling 397 participants across multiple countries.
Botulinum Toxin Type A 300U is a formulation of botulinum toxin type A, the same active ingredient used in Botox. However, the specific product name and dosage form may differ. The trial data refers to it as Botulinum Toxin Type A 300U.