A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines

Study Overview
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Brief Summary
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Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines. Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States. Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Official Title
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A Phase 2, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X for Forehead Lines

Conditions
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Forehead Lines

Intervention / Treatment
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* Drug: OnabotulinumtoxinA X
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation Exclusion Criteria: History of known immunization to any botulinum toxin serotype. History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class. Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including: Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function. History of Facial nerve palsy. Infection or dermatological condition at the site of study drug injection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo will be injected into the forehead on Day 1. | Drug: Placebo<br>* Intramuscular Injection<br>|
| Experimental: OnabotulinumtoxinA X Dose A<br>OnabotulinumtoxinA X will be injected into the forehead on Day 1. | Drug: OnabotulinumtoxinA X<br>* Intramuscular Injection<br>* Other names: OnabotA X;|
| Experimental: OnabotulinumtoxinA X Dose B<br>OnabotulinumtoxinA X will be injected into the forehead on Day 1. | Drug: OnabotulinumtoxinA X<br>* Intramuscular Injection<br>* Other names: OnabotA X;|
| Experimental: OnabotulinumtoxinA X Dose C<br>OnabotulinumtoxinA X will be injected into the forehead on Day 1. | Drug: OnabotulinumtoxinA X<br>* Intramuscular Injection<br>* Other names: OnabotA X;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | 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 investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. | Day 1 to Day 180 | 
| Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters | Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed. | Day 1 to Day 180 | 
| Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline on the investigator-rated clinician forehead lines Scale at maximum contraction. | The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe | Day 1 to Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forehead Lines, OnabotulinumtoxinA X