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

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

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.

Condition or disease Intervention/treatment Phase
Hemifacial Spasm Drug: Botulinum Toxin Type A Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Muscle Cramps

Arm Intervention/treatment
Placebo Comparator: unilateral injection group
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
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

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03306940


Contacts
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Contact: Lingjing Jin, PhD +86 02166111310 1164427300@qq.com
Contact: Libin Xiao, MBA +86 13916266214 xiaolibinjiayou@163.com

Locations
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China, Shanghai
Shanghai Tongji Hospital Recruiting
Shanghai, Shanghai, China, 200065
Contact: Lingjing Jin, PhD    +86 02166111310    1164427300@qq.com   
Contact: Libin Xiao, MBA    +86 13916266214    xiaolibinjiayou@163.com   
Sponsors and Collaborators
Tongji University
Investigators
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Principal Investigator: Lingjing Jin, PhD Shanghai Tongji Hospital, Tongji University School of Medicine

Publications of Results:
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Responsible Party: Lingjing Jin, professor, Tongji University
ClinicalTrials.gov Identifier: NCT03306940     History of Changes
Other Study ID Numbers: 14SG21
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lingjing Jin, Tongji University:
botulinum toxin A
Additional relevant MeSH terms:
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Muscle Cramp
Hemifacial Spasm
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents