Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OnabotulinumtoxinA · 12 trials · 11 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.
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).
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.
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. |
| placebo (normal saline) | PLACEBO_COMPARATOR | normal saline injected into bilateral Crow's Feet Line areas on Day 1. |
| 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. |
| OnabotulinumtoxinA 400 U | EXPERIMENTAL | OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. |
| OnabotulinumtoxinA 200 U | EXPERIMENTAL | OnabotulinumtoxinA 200 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. |
| onabotulinumtoxinA 50 U | EXPERIMENTAL | 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. |
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 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.