Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Patients

NCT04589364 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: STUDY NO. A-01-2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

A 50-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 100 unit of Abobotulinum Toxin Type A (Dysport®) versus 33.33 unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients, designed gor comparing the effectiveness of Total intensity score after 4. 12. 16 and 24 weeks of treatment and to compare the long-term safety of the injections. Abobotulinum toxin A (Dysport \*) dose 100 units compared ot neubotulinum toxin A injection (Neuronox / Neuronox®) dose 33.33 units. that it si non-inferiority (non-inferiority) ni the treatment of hemifacial spasm after administration of the drug ni the 0, 12" ,26", and 38" weeks ni the treatment of patients with hemi facial spasm, with a wash out period of 2 weeks between treatments. By proving the non-inferiority of Total intensity score at ,4 ,8 and12 week after treatment which calculated by severity score and duration of facial muscle spasm (hour per day)., as well as severity score and duration of functional impairment (hour per day) recorded for 4,8, and 21 weeks after each treatment between 33.33 unit of Neubotulinum Toxin Type A(Neuronox\*) and 100 unit of Abobotulinum Toxin Type A (Dysport\*)

Conditions

Hemifacial Spasm

Outcome Measures

Primary Outcomes (3)

• Total Intensity score

  Primary efficacy variable Comparesion of pre- and post- treatment at each injection (4 week) and over all after 12- and 24-week scale with 33.33 unit of Neubotulinum Toxin Type A(Neuronox®) and 100 unit of Abobotulinum Toxin Type A(Dysport®); as followings: 1\) Patient diary, the 24 hour HFS diary record for 12 weeks after treatment. Total intensity score at 4, 8, and 12 weeks after treatment \[which calculated by severity score and duration of facial muscle spasm (hour per day), as wel as severity score and duration of functional impairment (hour per day) recorded at 4, 8, and 12 weeks after each treatment will be assessed\].

  12 weeks

• Duration of functional impairment per day

  Primary efficacy variable Comparesion of pre- and post- treatment at each injection (4 week) and over all after 12- and 24-week scale with 33.33 unit of Neubotulinum Toxin Type A(Neuronox®) and 100 unit of Abobotulinum Toxin Type A(Dysport®); as followings: 1\) Patient diary, the 24 hour HFS diary record for 12 weeks after treatment. Duration of functional impairment at 4, 8, and 12 weeks after treatment \[which calculated by duration of facial muscle spasm which effect to functional impairment (hour per day),impairment recorded at 4, 8, and 12 weeks after each treatment will be assessed\].

  12 weeks

• Duration of facial muscle spasm per day

  Primary efficacy variable Comparesion of pre- and post- treatment at each injection (4 week) and over all after 12- and 24-week scale with 33.33 unit of Neubotulinum Toxin Type A(Neuronox®) and 100 unit of Abobotulinum Toxin Type A(Dysport®); as followings: 1\) Patient diary, the 24 hour HFS diary record for 12 weeks after treatment. Duration of facial muscle spasm at 4, 8, and 12 weeks after treatment \[which calculated by duration of facial muscle spasm which may or may not effect to functional impairment (hour per day),impairment recorded at 4, 8, and 12 weeks after each treatment will be assessed\].

  12 weeks

Secondary Outcomes (7)

• Hemifacial Spasm- 30 Questionnaire

  12 weeks

• Abnormal involuntary movement scale

  12 weeks

• 36-item questionnaire scale of general health quality of life

  12 weeks

• Center of Epidemiologic study -Depression scale (CES-D)

  12 weeks

• Patient health Questionnaire - 9 item (PHQ-9)

  12 weeks

Study Arms (2)

abobotulinum toxin A

EXPERIMENTAL

Abobotulinum Toxin Type A (Dysport) dose was investigated: dose: 100 units ( various units each site depend on clinical )

Drug: Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)

neubotulinum toxin A

EXPERIMENTAL

Neubotulinum Toxin Type A (Neuronox) dose was investigated: dose: 33.33 units ( various units each site depend on clinical )

Drug: Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)

Interventions

Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit) DRUG

injection of toxin on facial muscle

abobotulinum toxin A; neubotulinum toxin A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• The volunteer is pregnant or breastfeeding, or the volunteer si a woman at risk of pregnancy who has not received adequate pregnancy protection.
• Volunteers who have contraindications or precautions for injection. Botulinum toxin Aor hte need ot use drugs that may cause adverse reactions from Interactions between required drugs and investigational drugs such as aminoglycoside, spectinomycin, polymyxin tetracycline, and lincomycin antibiotics and tubocurarines muscle relaxant.
• The volunteer has an allergic reaction to hte drug or any substance related to the drug used for treatment.
• The volunteer is unable or unwilling to participate and follow al details in the research project. or not cooperating in completing questionnaires in the research project.
• The subject has received any other unregistered drugs or other experimental drugs within the past 6 months. Al types of botulinum toxin are allowed (patients can receive previous treatment with any type of botulinum toxin for more than 14 weeks or 98 The day before the Ist appointment).
• Volunteers who have been previously selected for this research project.
• Subjects with a history of botulism or co-morbidities such as neuromuscular junction disease such as myasthenia gravis. or Eaton Lumber Syndrome.
• Volunteers with other physical diseases or other neurological diseases or psychiatric disorders that may affect treatment. For example, having a history of blood clotting disorders (INR greater than 1.2), low blood platelets. Rheumatoid joint pain, heart attack, coronary artery disease Dementia Any type of psychosis or any other condition or risk factor for adverse reactions that may affect the results of the research.
• The volunteer has a history of being addicted to or using drugs or narcotics or has a history of allergic reaction to botulinum toxin.
• Subjects who received planned and treated surgery. throughout the research study period or patients receiving aminoglycosides or culale cannot participate in the research

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (4)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Lampang Hospital

Lampang, 52000, Thailand

Location

Surat Thani hospital

Surat Thani, 84000, Thailand

Location

Sappasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

Related Publications (1)

• Kongsengdao S, Kritalukkul S. Quality of life in hemifacial spasm patient after treatment with botulinum toxin A; a 24-week, double-blind, randomized, cross-over comparison of Dysport and Neuronox study. J Med Assoc Thai. 2012 Mar;95 Suppl 3:S48-54.

  PMID: 22619887 RESULT

MeSH Terms

Conditions

Hemifacial Spasm

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

subsai kongsaengdao, M.D.

CONTACT

+66818180890; skhongsa@gmail.com

Arkhom arayawichanon, M.D.

CONTACT

+66816653741; aarayawi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A 50-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 100 unit of Abobotulinum Toxin Type A (Dysport) versus 33.33 unit of Neubotulinum Toxin Type A (Neuronox) Injection For Hemifacial Spasm in Thai Patients

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 19, 2020
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4)