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Botulinum Toxin A in the Treatment of Hemifacial Spasm (BTATHS)

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ClinicalTrials.gov Identifier: NCT03306940
Recruitment Status : Unknown
Verified October 2017 by Lingjing Jin, Tongji University.
Recruitment status was:  Recruiting
First Posted : October 11, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Lingjing Jin, Tongji University

Tracking Information
First Submitted Date  ICMJE October 2, 2017
First Posted Date  ICMJE October 11, 2017
Last Update Posted Date October 12, 2017
Actual Study Start Date  ICMJE October 2, 2017
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Sunnybrook Facial Grading System [ Time Frame: up to 6 months ]
Sunnybrook Facial Grading System consists of resting symmetry, symmetry of voluntary movement and synkinesis. Total score = Symmetry of voluntary movement score - Resting symmetry score - Synkinesis score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Symmetry Scale for Hemifacial Spasm [ Time Frame: up to 6 months ]
    Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score
  • Facial Clinimetric Evaluation Scale [ Time Frame: up to 6 months ]
    Facial Clinimetric Evaluation Scale consists of six parts:facial movement,facial comfort,oral function,eye comfort,lacrimal control and social function. Total score = facial movement + facial comfort + oral function + eye comfort + lacrimal control + social function.
  • The effective duration of botulinum toxin A [ Time Frame: up to 6 months ]
    degree of amelioration in spasm and the effective duration of botulinum toxin A
  • Adverse events [ Time Frame: up to 6 months ]
    Adverse events, including stiff face, difficulty drinking and eating, difficulty controlling parotid and so on.The onset and duration of adverse events.Whether to take intervention to ameliorate adverse events and the efficacy of the intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin A in the Treatment of Hemifacial Spasm
Official Title  ICMJE Does Bilateral Botulinum Toxin A in Patients With Hemifacial Spasm Improve Facial Symmetry Unilateral and Bilateral Injection of Botulinum Toxin A in Patients With Hemifacial Spasm? A Prospective, Randomized, Controlled Study
Brief Summary Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups. Group A received unilateral injection while group B received bilateral injection. Patients completed follow-up A researcher record facial videos and analyzed facial symmetry and completed 3 scales.
Detailed Description

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups.Patients of unilateral group were injected to the affected side and the dose of botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site.

3 scales for measurement were used.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemifacial Spasm
Intervention  ICMJE Drug: Botulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site
Other Name: Chinese botulinum toxin type A
Study Arms  ICMJE
  • Placebo Comparator: unilateral injection group
    Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
    Intervention: Drug: Botulinum Toxin Type A
  • Experimental: bilateral injection group
    Patients of bilateral group were injected botulinum toxin type A to the affected hemiface and normal hemiface. The intervention of the bilateral group was that the normal side was injected.
    Intervention: Drug: Botulinum Toxin Type A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 5, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2018
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosis of hemifacial spasm
  • Scott grading III to IV
  • hemifacial spasm duration of half or more years
  • last botulinum toxin A application at least 3 months before the start of the study

Exclusion Criteria:

  • history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression
  • bilateral hemifacial spasm
  • allergies to botulinum toxin A or to any component of the drug
  • previous treatment with botulinum toxin A fewer than 3 months
  • the use of drugs that could interfere with neuromuscular transmission or spasm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03306940
Other Study ID Numbers  ICMJE 14SG21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lingjing Jin, Tongji University
Study Sponsor  ICMJE Tongji University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lingjing Jin, PhD Shanghai Tongji Hospital, Tongji University School of Medicine
PRS Account Tongji University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP