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Label indication BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication ( 1.1 ) Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal…
Also known as BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA
onabotulinumtoxinA 44 U · 18 trials · 17 indications
The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.
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 investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Patient will record the pain intensity by means of a visual analogue scale (VAS, from 0-10 being 0 no pain and 10 the worst possible pain)
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
Pulse rate measures the number of times your heart beats per minute.
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.
Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2. |
| Group 2 | EXPERIMENTAL | Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2. |
| Group 3 | EXPERIMENTAL | Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2. |
| Group 4 | EXPERIMENTAL | Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2. |
| BOTOX | EXPERIMENTAL | BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323 |
| Placebo | PLACEBO_COMPARATOR | Placebo will be injected into the platysma muscle on Day 1 |
| OnabotulinumtoxinA Dose A | EXPERIMENTAL | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| OnabotulinumtoxinA Dose B | EXPERIMENTAL | OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| Placebo followed by OnabotulinumtoxinA Dose A | PLACEBO_COMPARATOR | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. |
| OnabotulinumtoxinA | EXPERIMENTAL | OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| Placebo followed by OnabotulinumtoxinA in Period 2 | PLACEBO_COMPARATOR | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas. |
| 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). |
| 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. |
| onabotulinumtoxinA 24U | OTHER | 24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinumtoxinA 44U | EXPERIMENTAL | 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| placebo/onabotulinumtoxinA | OTHER | Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). |
| BOTOX® 72U | EXPERIMENTAL | OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1. |
| BOTOX® 48U | EXPERIMENTAL | OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1. |
| 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 |
| OnabotulinumtoxinA 400 U | EXPERIMENTAL | OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. |
| Placebo for onabotulinumtoxinA 50 U | PLACEBO_COMPARATOR | Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
| Placebo for onabotulinumtoxinA 30 U | PLACEBO_COMPARATOR | Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
| onabotulinumtoxinA 30 U | EXPERIMENTAL | OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
| Name | Type | Description |
|---|---|---|
| OnabotulinumtoxinA | DRUG | Intramuscular Injections |
| Placebo | DRUG | Intramuscular Injections |
| Normal Saline | DRUG | Placebo (normal saline) injected into the protocol-specified areas on Day 1. |
| Placebo (Normal Saline) | DRUG | Placebo (normal saline) is administered into the detrusor at Day 1. |
| onabotulinumtoxinA 44 U | BIOLOGICAL | 44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinumtoxinA 24 U | BIOLOGICAL | 24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinum toxin A | DRUG | Each subject will receive 50 units (50 U) of BoNT-A constituted in 1 mL of saline solution injected intraorally to the painful area divided in at least 3 sites, 0.5 to 1.0 cm apart depending on the size of the painful area and following a checkerboard pattern. |
| 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: * Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment. * Glabellar lines (GL) of moderate or severe rating at maximum contracti...
OnabotulinumtoxinA 44 U is being studied for the treatment of facial rhytides, including crow's feet lines and glabellar lines. It is an investigational formulation developed by AbbVie Inc. for aesthetic dermatology use, and it has been evaluated in a Phase 3 clinical trial in adults aged 18 years and older.
OnabotulinumtoxinA 44 U targets SNAP25, a protein involved in neurotransmitter release. It acts as an inhibitor of SNAP25. By inhibiting this target, the drug is designed to reduce muscle activity that contributes to facial rhytides such as crow's feet lines and glabellar lines.
OnabotulinumtoxinA 44 U is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor responsible for the clinical development of this investigational botulinum toxin type A formulation for facial rhytides.
OnabotulinumtoxinA 44 U is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for the treatment of facial rhytides. The Phase 3 trial evaluating it has been completed.
OnabotulinumtoxinA 44 U has been evaluated in the Phase 3 trial NCT01224015, titled "Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines." This completed, randomized, double-blind, placebo-controlled trial enrolled 684 participants across the United States, Canada, France, and Germany.