Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Pati… (NCT04589364) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Patients
Thailand120 participantsStarted 2024-05-01
Plain-language 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\*)
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Intensity score
Timeframe: 12 weeks
2
Duration of functional impairment per day
Timeframe: 12 weeks
3
Duration of facial muscle spasm per day
Timeframe: 12 weeks
Trial details
NCT IDNCT04589364
SponsorDepartment of Medical Services Ministry of Public Health of Thailand
. 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.