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

• ClinicalTrials.gov Identifier: NCT04589364
• Recruitment Status: Not yet recruiting
• First Posted: October 19, 2020
• Last Update Posted: September 17, 2021
• Sponsor: Rajavithi Hospital
• Information provided by (Responsible Party): Rajavithi Hospital

Study Description

Brief Summary:

A 48-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of, 100 unit of Abobotulinum Toxin Type A (Dysport) and 33.33 unit of Neubotulinum Toxin Type A (Neuronox) injection for Hemifacial Spasm in patient diagnosed with Hemifacial Spasm according to clinical diagnosis. It was designed to evaluate the efficacy, safety, tolerability, quality of life and the comparesion the improvement after treatment by of Abobotulinum Toxin Type A (Dysport) injection versus Neubotulinum Toxin Type A (Neuronox) Injection.

Condition or disease	Intervention/treatment	Phase
Hemifacial Spasm	Drug: Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)	Phase 3

Detailed Description:

The primary objective of the study was to evaluate the safety and efficacy of Abobotulinum Toxin Type A (Dysport) injection and Neubotulinum Toxin Type A (Neuronox) Injection for Hemifacial Spasm. The secondary objective of the study was to evaluate the quality of life of Abobotulinum Toxin Type A (Dysport) and Neubotulinum Toxin Type A (Neuronox) Injection for Hemifacial Spasm.

120 patients diagnosed with Hemifacial Spasm were planned to be enrolled into the study. Total of 120 patients planed to be and randomized.

Efficacy criteria:

Primary efficacy variable: Comparesion of pre- and post- treatment 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 following

1. 24 hours HFS diary record for 12 week after treatment Time to peak improvement, response duration period, Total intensity score per day, duration of facial muscle spasm (hour per day) and duration of functional impairment (hour per day) record for 12 week after each treatment will be assessed
2. Hemifacial Spasm- 30 Questionnaire (Thai version). Seven subscales (30 items). Mobility (5 items), activity of daily living (5 items) and communication (3 items) are classified as physical health domain. Emotional well-being (7 items), stigma (4 items), social support (3 items) and cognition (3 items) are classified as mental health domain
3. Abnormal involuntary movement scale (AIMS) (Thai version) Rating sacle of the severity of movements in 7 regions, each on a 5 points scale and a separate rating of the overall severity of the abnormal movements, judged on the amplitude of movements, incapacitation postures and positions, including sitting in chair, opening the mouth, tapping the thumb against each finger, holding the hand out stretched and standing and walking, are included. Dental status is also rated, as the presence or absence of problems with teeth or dentures.

Secondary efficacy variables: : Comparesion of pre- and post- treatment after 12 and 24 week scale with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport); as following

1. 36-item questionnaire and comprises eight domains: Physical functioning (PF), Role limitations due to physical health (RP), Role limitations due to emotional problems(RE), Vitality (VT), Mental health (MH), Social functioning (SF), Bodily pain (BP), General health (GH)
2. Center of Epidemiologic study -Depression scale (CES-D)
3. Patient health Questionnaire - 9 item (PHQ-9)
4. The investigator's /patient's global assessment of change (GAC) Safety criteria: The assessment of safety and tolerability were based mainly on the frequency of adverse events.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A 48-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
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double blinded
• Primary Purpose: Treatment
• Official Title: A 48-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of 100 Unit of Abobotulinum Toxin Type A (Dyspor) Versus 33.33 Unit of Neubotulinum Toxin Type A (Neuronox) Injection For Hemifacial Spasm in Thai Patients
• Estimated Study Start Date: January 1, 2022
• Estimated Primary Completion Date: March 1, 2022
• Estimated Study Completion Date: April 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: abobotulinum toxin A; 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); injection of toxin on facial muscle
Experimental: neubotulinum toxin A; 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); injection of toxin on facial muscle

Outcome Measures

Primary Outcome Measures :

1. Time to peak improvement [ Time Frame: 12 weeks ]
   day of latency to treatment peak effectiveness
2. response duration period [ Time Frame: 12 weeks ]
   day of duration to treatment peak effectiveness
3. Total intensity score per day [ Time Frame: 12 weeks ]
   severity and duration calculated score from patient diary range between 0-6048 higher score mean worse
4. duration of facial muscle spasm [ Time Frame: 12 weeks ]
   duration calculated score from patient diary outcome measure as hour per 12 week
5. duration of functional impairment [ Time Frame: 12 weeks ]
   duration of functional impairment calculated score from patient diary outcome measure as hour per 12 week
6. Hemifacial Spasm- 30 [ Time Frame: 12 weeks ]
   Seven subscales (30 items). Mobility (5 items), activity of daily living (5 items) and communication (3 items) are classified as physical health domain. Emotional well-being (7 items), stigma (4 items), social support (3 items) and cognition (3 items) are classified as mental health domain higher score represent worse ( range from 0-120 higher score represent worse)
7. Abnormal involuntary movement scale (AIMS) [ Time Frame: 12 weeks ]
   Rating sacle of the severity of movements in 7 regions, each on a 5 points scale and a separate rating of the overall severity of the abnormal movements, judged on the amplitude of movements, incapacitation postures and positions, including sitting in chair, opening the mouth, tapping the thumb against each finger, holding the hand out stretched and standing and walking, are included. Dental status is also rated, as the presence or absence of problems with teeth or dentures

Secondary Outcome Measures :

1. 36-item questionnaire [ Time Frame: 12 weeks ]
   36-item questionnaire and comprises eight domains: Physical functioning (PF), Role limitations due to physical health (RP), Role limitations due to emotional problems(RE), Vitality (VT), Mental health (MH), Social functioning (SF), Bodily pain (BP), General health (GH) Special calculation of this scale are specified
2. Center of Epidemiologic study -Depression scale (CES-D) [ Time Frame: 12 weeks ]
   20 item depressive screening scale ( range 0-80 higher score represent worse)
3. Patient health Questionnaire - 9 item (PHQ-9) [ Time Frame: 12 weeks ]
   9 item depressive screening scale range between 0-27 higher score represent worse
4. The investigator's /patient's global assessment of change [ Time Frame: 12 weeks ]
   5 scale evaluate clinical status range from -3 to 3 higher score represent good outcome

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject.
• Able to give written inform consent and retained one copy of the consent form
• Male or female subject, aged between 20 - 100 years old.
• Subject diagnosed to be hemifacial spasm.
• Female subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).
• Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.

Subject should undergo a normal physical and neurological examination HFS 30, AIMS, SF36, and CES-D, PHQ 9 , and patient diary

Exclusion Criteria:

• The subject was pregnant or lactating.
• The subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.
• The subject had a known hypersensitivity to any of the test materials or related compounds.
• The subject was unable or unwilling to comply fully with the protocol.
• The subject received any unlicensed drug within the previous 6 months.
• Treatment with investigational drug (s) within 6 months before the screening visit.
• The subject had previously entered in this study.
• Subject with past history of botulism, other neuromuscular disorder (e.g. myasthenia gravis, Lambert - Elton Syndrome)
• Subject with significant medical / neurological / psychiatric disorders such as blood dyscrasia, thrombocytopenia, INR>1.2 rheumatoid arthritis, congestive heart failure, coronary artery heart diseases, dementia, psychosis, or other conditions which could influence the clinical trial.
• Known history of drug abuse (narcotic (s), cafergot, or others) or drug (botulinum toxin type A) allergy.
• Unable to cooperate fill-up HFS 30, AIMS, SF36, and CES-D
• Patient who planned to schedule elective surgery during the study.
• The used of aminoglycoside antibiotics and curare were not allowed during the study.

Contacts and Locations

Contacts

Contact: subsai kongsaengdao, M.D.; +66818180890; skhongsa@gmail.com

Contact: Arkhom arayawichanon, M.D.; +66816653741; aarayawi@gmail.com

Locations

Thailand

Rajavithi Hospital

Bangkok, Thailand, 10400

Lampang Hospital

Lampang, Thailand, 52000

Surat Thani hospital

Surat Thani, Thailand, 84000

Sappasitthiprasong Hospital

Ubon Ratchathani, Thailand, 34000

Sponsors and Collaborators

Rajavithi Hospital

More Information

Publications of Results:

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.

• Responsible Party: Rajavithi Hospital
• ClinicalTrials.gov Identifier: NCT04589364
• Other Study ID Numbers: STUDY NO. A-01-2020
• First Posted: October 19, 2020
• Last Update Posted: September 17, 2021
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hemifacial Spasm; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System 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