Trial Outcomes & Findings for Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis (NCT NCT03048383)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.

Results posted on

2017-07-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	28	21	22
Overall Study COMPLETED	15	13	10
Overall Study NOT COMPLETED	13	8	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OnabotulinumtoxinA Injectable Product n=15 Participants 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 n=13 Participants 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 n=10 Participants 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 n=38 Participants Total of all reporting groups
Age, Continuous	43.9 years n=5 Participants	52.1 years n=7 Participants	53.2 years n=5 Participants	49.1 years n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Pre-treatment SAQ score	79.6 units on a scale STANDARD_DEVIATION 15.1 • n=5 Participants	70.1 units on a scale STANDARD_DEVIATION 15.3 • n=7 Participants	69.6 units on a scale STANDARD_DEVIATION 9.7 • n=5 Participants	73.7 units on a scale STANDARD_DEVIATION 14.4 • n=4 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.

Population: The Synkinesis Assessment Questionnaire (SAQ) was used to assess severity of facial synkinesis for each group. Total SAQ scores can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe.

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).

Outcome measures

Outcome measures
Measure	OnabotulinumtoxinA Injectable Product n=15 Participants 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 n=13 Participants 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 n=10 Participants 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
Change in Synkinesis Assessment Questionnaire (SAQ) Scores 4 weeks post-treatment SAQ score	46.4 units on a scale Standard Deviation 15.4	40.3 units on a scale Standard Deviation 16.0	58.0 units on a scale Standard Deviation 11.6
Change in Synkinesis Assessment Questionnaire (SAQ) Scores 2 weeks post-treatment SAQ score	45.2 units on a scale Standard Deviation 15.4	37.6 units on a scale Standard Deviation 12.2	49.8 units on a scale Standard Deviation 11.8
Change in Synkinesis Assessment Questionnaire (SAQ) Scores 1 week post-treatment SAQ score	45.9 units on a scale Standard Deviation 13.9	38.8 units on a scale Standard Deviation 10.8	51.3 units on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OnabotulinumtoxinA Injectable Product n=15 Participants 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 n=13 Participants 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 n=10 Participants 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
Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events

Adverse Events

OnabotulinumtoxinA Injectable Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AbobotulinumtoxinA Injectable Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Incobotulinumtoxin A Injectable Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. P. Daniel Ward

University of Utah

Phone: 801-581-8471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place