Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BOTOX · 9 trials · 7 indications
The investigator and participant each assessed the participant's Masseter Muscle Prominence (MMP) using the Masseter Muscle Prominence Scale (MMPS) and the Masseter Muscle Prominence Scale-Participant (MMPS-P), respectively. Both are a 5-point masseter muscle severity scale with grades ranging from 1 (minimal/not at all noticeable) to 5 (very marked/extremely noticeable).
An 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 causal relationship with this treatment.
The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.
The participant assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.
The MMPS is a photonumeric scale encompassing visual inspection of the masseter muscles as performed by the investigator, where the masseter muscle prominence (MMP) is rated at rest, by separately evaluating the left and right side of the participant's face. The evaluation is on a 5-grade scale where 1 = the masseter muscle prominence is minimal and 5 = the masseter muscle prominence is very marked.
The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst).
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst).
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
Tremor Disability Scale-Revised (TREDS-R) is a scale to assess activities of daily living (ADL) through a self-questionnaire asking participants to rate how easy or difficult it is to perform a particular activity. The scale consists of 20 items with each item rated on a scale of 1 (able to do the activity without difficulty) to 4 (cannot do the activity by yourself). 7 items included in this subset will be: use a spoon to drink soup, hold a cup of tea, pour milk from a bottle or carton, dial a telephone, pick up your change in a shop, insert an electric plug into a socket, unlock your front door with a key.
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.
Daily worst bladder pain will be assessed on the 11-point (0-10) numeric rating scale where 0 = no pain and 10 = the worst pain possible.
Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in vital signs from the Baseline visit.
Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in physical exams from the Baseline visit.
Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Period: BOTOX | EXPERIMENTAL | Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1. |
| Double-Blind Period: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo injections across both the right and left masseter muscle on Day 1. |
| Open-Label Period: BOTOX | EXPERIMENTAL | Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months. |
| BOTOX | EXPERIMENTAL | BOTOX will be injected on Day 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo will be injected on Day 1 |
| Group 1 | EXPERIMENTAL | In Period 1, participant will receive 6 injections of BOTOX VISTA Dose A on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270. |
| Group 2 | EXPERIMENTAL | In Period 1, participant will receive 6 injections of BOTOX VISTA Dose B on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270. |
| Group 3 | EXPERIMENTAL | In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270. |
| Group 4 | EXPERIMENTAL | In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270. |
| Double Blind Period: Placebo | PLACEBO_COMPARATOR | Participants will receive 6 intramuscular injections of Placebo to the masseter on Day 1. |
| BOTOX® | EXPERIMENTAL | Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection. |
| solifenacin | ACTIVE_COMPARATOR | Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| BOTOX/BOTOX Unilateral | EXPERIMENTAL | Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3 |
| BOTOX/BOTOX Bilateral | EXPERIMENTAL | Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3 |
| Placebo/BOTOX Unilateral | EXPERIMENTAL | Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3. |
| Placebo/BOTOX Bilateral | EXPERIMENTAL | Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3. |
| Open Label BOTOX | EXPERIMENTAL | Participants will receive BOTOX at Baseline (Day 1) |
| Double-Blind Randomized BOTOX | EXPERIMENTAL | Participants will receive BOTOX at Baseline (Day 1) |
| Double Blind Randomized Placebo | PLACEBO_COMPARATOR | Participants will receive placebo at Baseline (Day 1) |
| Name | Type | Description |
|---|---|---|
| BOTOX | DRUG | Intramuscular Injections |
| Placebo | DRUG | Intramuscular Injections |
| Placebo for BOTOX | DRUG | Intramuscular Injection |
| BOTOX® | BIOLOGICAL | BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection. |
| solifenacin | DRUG | Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks. |
| Botox placebo (normal saline) | DRUG | Botox placebo (normal saline) intradetrusor injection at Day 1. |
| solifenacin placebo | DRUG | Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks. |
Inclusion Criteria: * Participant meets the following criteria: * Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS). * Bilateral Grade 4 or G...
BOTOX is a small molecule developed by AbbVie Inc. that is being studied for several conditions, including Overactive Bladder, Upper Limb Essential Tremor (UL ET), Masseter Muscle Prominence, Facial Fine Lines, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), and Forehead Lines. It is in clinical development and is not approved for these uses.
BOTOX is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
BOTOX is in Phase 3 clinical development for Overactive Bladder and Masseter Muscle Prominence, based on completed trials. It has also been studied in Phase 2 for Upper Limb Essential Tremor and Phase 1 for Facial Fine Lines. The drug remains investigational.
BOTOX has completed four clinical trials, including NCT01767519 for Overactive Bladder, NCT04631588 for Facial Fine Lines, NCT05216250 for Upper Limb Essential Tremor, and NCT06068855 for Masseter Muscle Prominence. All trials are completed with a total enrollment of 917 participants.
BOTOX is a brand name for botulinum toxin type A, as referenced in the clinical trial NCT06068855. The drug is being evaluated for its effects on conditions such as Masseter Muscle Prominence and other indications listed in its development program.