Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis

NCT03048383 | Completed Phase 4 Results DMC

• 1 other identifier: 56158
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Facial Nerve Injuries; Facial Paresis Associated With Facial Nerve Dysfunction; Facial Asymmetry; Synkinesis

Keywords

Facial paralysis; Facial synkinesis; Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Change in Synkinesis Assessment Questionnaire (SAQ) Scores

  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).

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

Secondary Outcomes (1)

• Adverse Events

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

Study Arms (3)

OnabotulinumtoxinA Injectable Product

ACTIVE COMPARATOR

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

AbobotulinumtoxinA Injectable Product

ACTIVE COMPARATOR

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

Incobotulinumtoxin A Injectable Product

ACTIVE COMPARATOR

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

Interventions

OnabotulinumtoxinA Injectable Product DRUG

Administered to treat facial synkinesis

Also known as: Botox

OnabotulinumtoxinA Injectable Product

AbobotulinumtoxinA Injectable Product DRUG

Administered to treat facial synkinesis

Also known as: Dysport

AbobotulinumtoxinA Injectable Product

Incobotulinumtoxin A Injectable Product DRUG

Administered to treat facial synkinesis

Also known as: Xeomin

Incobotulinumtoxin A Injectable Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Facial synkinesis

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Related Publications (8)

• Choi KH, Rho SH, Lee JM, Jeon JH, Park SY, Kim J. Botulinum toxin injection of both sides of the face to treat post-paralytic facial synkinesis. J Plast Reconstr Aesthet Surg. 2013 Aug;66(8):1058-63. doi: 10.1016/j.bjps.2013.04.012. Epub 2013 May 15.

  PMID: 23683725 BACKGROUND

• Nettar KD, Yu KC, Bapna S, Boscardin J, Maas CS. An internally controlled, double-blind comparison of the efficacy of onabotulinumtoxinA and abobotulinumtoxinA. Arch Facial Plast Surg. 2011 Nov-Dec;13(6):380-6. doi: 10.1001/archfacial.2011.37. Epub 2011 Jun 20.

  PMID: 21690460 BACKGROUND

• Saad J, Gourdeau A. A direct comparison of onabotulinumtoxina (Botox) and IncobotulinumtoxinA (Xeomin) in the treatment of benign essential blepharospasm: a split-face technique. J Neuroophthalmol. 2014 Sep;34(3):233-6. doi: 10.1097/WNO.0000000000000110.

  PMID: 24739994 BACKGROUND

• Mehta RP, WernickRobinson M, Hadlock TA. Validation of the Synkinesis Assessment Questionnaire. Laryngoscope. 2007 May;117(5):923-6. doi: 10.1097/MLG.0b013e3180412460.

  PMID: 17473697 BACKGROUND

• Filipo R, Spahiu I, Covelli E, Nicastri M, Bertoli GA. Botulinum toxin in the treatment of facial synkinesis and hyperkinesis. Laryngoscope. 2012 Feb;122(2):266-70. doi: 10.1002/lary.22404. Epub 2012 Jan 17.

  PMID: 22252570 BACKGROUND

• Armstrong MW, Mountain RE, Murray JA. Treatment of facial synkinesis and facial asymmetry with botulinum toxin type A following facial nerve palsy. Clin Otolaryngol Allied Sci. 1996 Feb;21(1):15-20. doi: 10.1111/j.1365-2273.1996.tb01018.x.

  PMID: 8674216 BACKGROUND

• Naumann M, Albanese A, Heinen F, Molenaers G, Relja M. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol. 2006 Dec;13 Suppl 4:35-40. doi: 10.1111/j.1468-1331.2006.01652.x.

  PMID: 17112348 BACKGROUND

• Thomas AJ, Larson MO, Braden S, Cannon RB, Ward PD. Effect of 3 Commercially Available Botulinum Toxin Neuromodulators on Facial Synkinesis: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2018 Mar 1;20(2):141-147. doi: 10.1001/jamafacial.2017.1393.

  PMID: 28973094 DERIVED

MeSH Terms

Conditions

Facial Nerve Injuries; Facial Asymmetry; Synkinesis; Facial Paralysis

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Paralysis

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

Re-enrollment of patients already treated with botulinum toxin for synkinesis (treated as unique patients); small sample size of patients/treatments.

Results Point of Contact

• Title: Dr. P. Daniel Ward
• Organization: University of Utah

PDanielWard@hsc.utah.edu

801-581-8471

Study Officials

• Preston D Ward, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 9, 2017
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share