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Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis

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ClinicalTrials.gov Identifier: NCT03048383
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare the effectiveness of three commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported outcome measures.

Condition or disease Intervention/treatment Phase
Facial Nerve Injuries Facial Paresis Associated With Facial Nerve Dysfunction Facial Asymmetry Synkinesis Drug: OnabotulinumtoxinA Injectable Product Drug: AbobotulinumtoxinA Injectable Product Drug: Incobotulinumtoxin A Injectable Product Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Single-blind Comparison of Three Commercially Available Botulinum Neuromodulators in the Management of Facial Synkinesis
Study Start Date : July 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: OnabotulinumtoxinA Injectable Product
onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Drug: OnabotulinumtoxinA Injectable Product
Administered to treat facial synkinesis
Other Name: Botox
Active Comparator: AbobotulinumtoxinA Injectable Product
abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Drug: AbobotulinumtoxinA Injectable Product
Administered to treat facial synkinesis
Other Name: Dysport
Active Comparator: Incobotulinumtoxin A Injectable Product
incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Drug: Incobotulinumtoxin A Injectable Product
Administered to treat facial synkinesis
Other Name: Xeomin


Outcome Measures

Primary Outcome Measures :
  1. Change in Synkinesis Assessment Questionnaire (SAQ) Scores [ Time Frame: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks. ]

    The previously validated instrument, Synkinesis Assessment Questionnaire (SAQ), was administered in order to evaluate patient-perceived severity of synkinesis. This instrument was used for each of the three treatment arms and change in scores from baseline were compared at each time point between arms.

    SAQ scores are calculated as the sum of scores for 9 questions, which each is scored from 1 to 5, divided by 45 and multiplied by 100. The total score therefore can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe. We report here the mean total SAQ score each group. For additional information on the SAQ for facial synkinesis see Mehta et al. published in Laryngoscope in May 2007 (PMID: 17473697).



Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks. ]
    We hypothesized that common minor events such as bruising and swelling at injection sites would occur equally for all treatment arms, but that no major adverse treatment effects would occur for any of the treatment arms. Major events are recorded here.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Facial synkinesis

Exclusion Criteria:

  • Previous complication from botulinum toxin neuromodulator injection
  • Inability to understand or complete the SAQ survey
  • Inability to participate in follow-up
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048383


Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Preston D Ward, MD University of Utah
More Information

Publications:

Responsible Party: Preston Ward, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT03048383     History of Changes
Other Study ID Numbers: 56158
First Posted: February 9, 2017    Key Record Dates
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is to be shared among the first author of the study and the principal investigator for purposes of data acquisition and analysis. This data will be limited to that necessary to addressing the research question, specifically, the type of botulinum toxin used for treatment, the dates of treatment, and the SAQ scores at the pre-treatment, and post-treatment follow-up visits. Any adverse events related to treatment will also be available.

Keywords provided by Preston Ward, University of Utah:
Facial paralysis
Facial synkinesis
Botulinum toxin

Additional relevant MeSH terms:
Facies
Paresis
Facial Asymmetry
Synkinesis
Facial Paralysis
Facial Nerve Injuries
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Dyskinesias
Mouth Diseases
Stomatognathic Diseases
Paralysis
Facial Nerve Diseases
Cranial Nerve Injuries
Cranial Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Neurotransmitter Agents
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents