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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):
Preston Ward, University of Utah

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Facial Nerve Injuries
Facial Paresis Associated With Facial Nerve Dysfunction
Facial Asymmetry
Synkinesis
Interventions: Drug: OnabotulinumtoxinA Injectable Product
Drug: AbobotulinumtoxinA Injectable Product
Drug: Incobotulinumtoxin A Injectable Product

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were prospectively enrolled from July 2012 to March 2015. All patients 18 years and older with facial synkinesis, who presented to our tertiary care Facial Nerve Center for treatment and were appropriate candidates for botulinum toxin chemodenervation therapy, were offered voluntary participation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria included previous complication from botulinum toxin neuromodulator injection, inability to understand or complete the SAQ survey, inability to participate in follow-up, and pregnancy. Informed consent was obtained from each patient before enrollment in the study.

Reporting Groups
  Description
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.

OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis

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.

AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis

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.

Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis


Participant Flow:   Overall Study
    OnabotulinumtoxinA Injectable Product   AbobotulinumtoxinA Injectable Product   Incobotulinumtoxin A Injectable Product
STARTED   28   21   22 
COMPLETED   15   13   10 
NOT COMPLETED   13   8   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis

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.

AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis

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.

Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis

Total Total of all reporting groups

Baseline Measures
   OnabotulinumtoxinA Injectable Product   AbobotulinumtoxinA Injectable Product   Incobotulinumtoxin A Injectable Product   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   13   10   38 
Age 
[Units: Years]
Mean (Full Range)
 43.9 
 (24 to 76) 
 52.1 
 (21 to 83) 
 53.2 
 (32 to 73) 
 49.1 
 (21 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      10  66.7%      7  53.8%      6  60.0%      23  60.5% 
Male      5  33.3%      6  46.2%      4  40.0%      15  39.5% 
Pre-treatment SAQ score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 79.6  (15.1)   70.1  (15.3)   69.6  (9.7)   73.7  (14.4) 
[1] The Synkinesis Assessment Questionnaire (SAQ) was used to assess severity of facial synkinesis in this study. 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).


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Adverse Events   [ Time Frame: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Re-enrollment of patients already treated with botulinum toxin for synkinesis (treated as unique patients); small sample size of patients/treatments.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. P. Daniel Ward
Organization: University of Utah
phone: 801-581-8471
e-mail: PDanielWard@hsc.utah.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Preston Ward, University of Utah
ClinicalTrials.gov Identifier: NCT03048383     History of Changes
Other Study ID Numbers: 56158
First Submitted: February 2, 2017
First Posted: February 9, 2017
Results First Submitted: May 6, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017