Can a Lower-Dose botox match the standard for hemifacial spasm?
NCT ID NCT04589364
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial tests whether a lower dose of one botulinum toxin type A (Neuronox) works as well as a higher dose of another (Dysport) for treating hemifacial spasm, a condition causing involuntary facial muscle twitching. About 107 adults with hemifacial spasm will receive both treatments in a random order, with a washout period in between. The study measures how well each injection reduces spasm severity and duration over several weeks, aiming to see if the lower-dose option is non-inferior.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Botulinum toxin type A injections (Dysport or Neuronox)
- What this could lead to
- If successful, this could show that a lower-cost botulinum toxin option works as well as a standard one, offering more choices for treating hemifacial spasm.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all patients. Injections can cause temporary facial weakness or bruising, and the lower dose might be less effective in some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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107 people
The number who actually took part.
- Started
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May 2024
- Finished
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Aug 2026
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
The subjects need to satisfy the following criteria before being allowed to participate ni the study: 1. Volunteers with hemifacial spasm aged 18 to 80 years who may or may not have received Botulinum toxin before. 2. Subjects were diagnosed with hemifacial spasm by a neurologist. 3. Healthy female volunteers of reproductive age must obtain informed consent from the study physician to avoid pregnancy throughout the study by using condoms or an appropriate method of birth control. too Female volunteers will be required to consent ot a urine pregnancy test before entering the study and throughout the study. There will be a pregnancy test using a urine test strip every time fi menstruation is over. 4. Volunteers must be evaluated for reliability ni participating ni the research project and volunteers or relatives can record treatment results. and side effects or drugs used in treatment They are willing to participate in the research project and understand the benefits of participating in the study. 5. The patient has had other normal physical examinations and si able ot undergo a neurological examination as wel as Able ot participate ni physical examinations ot assess symptoms of hemifacial spasm and can cooperate ni completing the AIMS questionnaire, HFS30, 36-item quality of life questionnaire, PHQ9, and the CES-D depression questionnaire. Exclusion Criteria Criteria for exclusion from the study Patients cannot participate in the research project fi they have the following conditions: 1. The volunteer is pregnant or breastfeeding, or the volunteer si a woman at risk of pregnancy who has not received adequate pregnancy protection. 2. 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. 3. The volunteer has an allergic reaction to hte drug or any substance related to the drug used for treatment. 4. 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. 5. 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). 6. Volunteers who have been previously selected for this research project. 7. Subjects with a history of botulism or co-morbidities such as neuromuscular junction disease such as myasthenia gravis. or Eaton Lumber Syndrome. 8. 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. 9. The volunteer has a history of being addicted to or using drugs or narcotics or has a history of allergic reaction to botulinum toxin. 10. Subjects who received planned and treated surgery. throughout the research study period or patients receiving aminoglycosides or culale cannot participate in the research
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lampang Hospital
Lampang, 52000, Thailand
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Rajavithi Hospital
Bangkok, 10400, Thailand
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Sappasitthiprasong Hospital
Ubon Ratchathani, 34000, Thailand
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Surat Thani hospital
Surat Thani, 84000, Thailand
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