A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Keywords

• OnabotulinumtoxinA X
• BOTOX
• Glabellar Lines

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted after Allergan became part of AbbVie.

Study arms

• Placebo comparator
  Placebo

  Placebo will be injected into the Glabellar Complex on Day 1.

  Drug: Placebo

• Experimental
  OnabotulinumtoxinA X Dose A

  OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.

  Drug: OnabotulinumtoxinA X

• Experimental
  OnabotulinumtoxinA X Dose B

  OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.

  Drug: OnabotulinumtoxinA X

• Experimental
  OnabotulinumtoxinA X Dose C

  OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.

  Drug: OnabotulinumtoxinA X

Interventions

• DrugOnabotulinumtoxinA X

  Injection

• DrugPlacebo

  Injection

Primary outcomes

1. Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.

   The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe

   Time frame: Day 1 to Day 30

2. Percentage of Participants With Adverse Events (AEs)

   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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

   Time frame: Day 1 to Day 270

Secondary outcomes

1. Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.

   The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe

   Time frame: Day 1 to Day 30

2. Percentage of Participants With Achievement of Improvement Per the Facial Lines Satisfaction Questionnaire Impact Domain, Among Subjects With Baseline Scores of 14 Points or Greater.

   The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. Domain scores are calculated as the mean of transformed item scores on a 0 (low impact) to 100 (highest negative impact) scale.

   Time frame: Day 1 to Day 30

3. Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.

   The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. A score of 100 represents the best score (very satisfied) and a score of 0 represent the worst score (very dissatisfied) on the satisfaction domain or satisfaction single items.

   Time frame: Day 1 to Day 60

Baseline characteristics

Study documents

• Study protocol ↗ · Feb 7, 2022
• Statistical analysis plan ↗ · Dec 12, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Data sharing details ↗ · vivli.org