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OnabotulinumtoxinA and Hydrogel admixture · 4 trials · 4 indications
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.
An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
| Arm | Type | Description |
|---|---|---|
| OnabotulinumtoxinA 50 U | EXPERIMENTAL | Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). |
| OnabotulinumtoxinA 100 U | EXPERIMENTAL | Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). |
| OnabotulinumtoxinA 200 U | EXPERIMENTAL | Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). |
| OnabotulinumtoxinA | EXPERIMENTAL | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA 100 U injection. |
| Placebo (Normal Saline) | OTHER | Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection. |
| 100U cohort - BOTOX® plus Hydrogel admixture | EXPERIMENTAL | 100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 100U cohort - Placebo plus Hydrogel admixture | PLACEBO_COMPARATOR | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 300U cohort - BOTOX® plus Hydrogel admixture | EXPERIMENTAL | 300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 300U cohort - Placebo plus Hydrogel admixture | PLACEBO_COMPARATOR | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 400U cohort - BOTOX® plus Hydrogel admixture | EXPERIMENTAL | 400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 400U cohort - Placebo plus Hydrogel admixture | PLACEBO_COMPARATOR | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 500U cohort - BOTOX® plus Hydrogel admixture | EXPERIMENTAL | 500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| 500U cohort - Placebo plus Hydrogel admixture | PLACEBO_COMPARATOR | Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1 |
| Name | Type | Description |
|---|---|---|
| OnabotulinumtoxinA | BIOLOGICAL | OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses. |
| Placebo (Normal Saline) | DRUG | Placebo (normal saline) is administered into the detrusor at Day 1. |
| OnabotulinumtoxinA and Hydrogel admixture | DRUG | BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation |
| Placebo and Hydrogel admixture | DRUG | Placebo and Hydrogel admixture administered as a single intravesical instillation |
Inclusion Criteria: * Successfully completed participation in Study 191622-120 * Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120 * Regularly using clean intermittent catheterization to empty the bladder Exclusion Criteria: * Myasthenia gravis, Eaton-Lambert syndrome, or am...
OnabotulinumtoxinA is used for forehead lines, neuropathic pain, osteoarthritis, overactive bladder, urinary incontinence, and forehead rhytides. It is being studied in clinical trials for these conditions, including lateral canthus rhytides (crow's feet lines) and urinary incontinence due to neurogenic detrusor overactivity in multiple sclerosis patients.
OnabotulinumtoxinA is a monoclonal antibody that targets the neuromuscular junction. It works by blocking the release of acetylcholine from nerve endings, which temporarily paralyzes muscles. This mechanism is used to treat conditions like forehead lines and overactive bladder by reducing muscle activity.
OnabotulinumtoxinA is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
OnabotulinumtoxinA is in Phase 3 clinical development for some indications, with Phase 2 trials also completed. It is an investigational drug and has not been approved by the FDA for the studied indications. The clinical program includes four completed trials with a total enrollment of 1,126 participants.
OnabotulinumtoxinA has completed four clinical trials, including NCT01189747 for crow's feet lines, NCT01600716 for urinary incontinence in multiple sclerosis, NCT02230956 for knee osteoarthritis, and NCT03320850 for overactive bladder. All trials were randomized, double-blind, and placebo-controlled.
OnabotulinumtoxinA is the same as BOTOX. Clinical trials reference BOTOX in their titles, such as NCT02230956 for knee osteoarthritis and NCT03320850 for overactive bladder. The drug is being studied under the brand name BOTOX by AbbVie.