Primary blepharospasm
Conditions
Interventions
investigational drug-A:Botulinum Toxin Type A for Injection (148 kDa, without complex proteins), administered by intramuscular injection, 26-32 Units
investigational drug-B:Botulinum Toxin Type A for Injection (148 kDa, without complex proteins), administered by intramuscular injection, 39-48 Units
placebo:Simulant of Botulinum Toxin Type A for Injection, administered by intramuscular injection, 0 Unit
Positive drug:BOTOX?/Botox? (Botulinum Toxin Type A for Injection), administered by intramuscular injection, 39-48 Units
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged between 18 and 75 years old (including the boundary values). 2. Subjects clinically diagnosed with primary blepharospasm. 3. The total score of the subject on the Jankivoc Rating Scale (JRS) is greater than 2. 4. For subjects who are stably taking antispasmodic drugs, they should have been using the drugs stably for at least 1 month before randomization and keep the dosage unchanged during the study period. For those who have previously taken antispasmodic drugs but have suspended taking them before randomization, they should discontinue the use for 5 half-lives or more. 5. Be able to understand and cooperate with the clinical research process, and be able to comply with the requirements of the research protocol until the completion of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have previously received treatment measures such as orbicularis oculi muscle resection or facial nerve block, and whose influence on the curative effect of the trial is judged by the researcher. 2. Subjects with a history of allergic reactions to botulinum toxin products and those with a previous history of severe allergies. 3. Subjects who have previously received = 2 treatments with botulinum toxin products for blepharospasm and all of these treatments have shown ineffectiveness. 4. The subject currently has an ocular infection (subjects with dry eye disease can be enrolled; patients with chronic conjunctivitis accompanied by dry eye disease can be enrolled; patients with acute conjunctivitis caused by bacterial or viral infections will be excluded). 5. Subjects with cranial segment dystonia or unilateral hemifacial spasm. 6. Subjects with a previous history of epilepsy, or those who, as evaluated by the researcher, have severe cognitive impairment or mental illness that may affect the implementation or evaluation of the trial. 7. Subjects who have used any of the following drugs within 4 weeks before screening: drugs that may affect neuromuscular function, including muscle relaxants (such as tubocurarine chloride, dantrolene sodium, baclofen, etc.) and anticholinergic drugs (such as bromobutane, trihexyphenidyl hydrochloride, glycopyrronium bromide, oxybutynin, etc.). 8. Any medical conditions that may increase the risk of patients when using Botulinum Toxin Type A, including those diagnosed with myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or other diseases that may interfere with neuromuscular function. 9. The subject has used similar drugs (botulinum toxin of any serotype) within 3 months before screening. 10. Pregnant or lactating women, or female subjects who have had unprotected sexual intercourse within the past two weeks, or female subjects with a positive pregnancy test; subjects (or their partners) who have a plan for childbearing or donating sperm/eggs during the entire trial period and within 6 months after the end of the study, or those who are unwilling to adopt one or more contraceptive measures during the trial period and within 6 months after the end of the study. 11. The subject is participating in another clinical trial, or the subject has participated in another clinical trial within 30 days before screening, or the time elapsed from the use of the drug in the previous clinical trial participated by the subject to the screening time is less than 5 times the half-life of the drug. 12. Subjects who will use prohibited concomitant medications during the study period. 13. Subjects who are unable to communicate or do not follow instructions. 14. Subjects whom the researcher deems inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Jankovic Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression Scale;Blepharospasm Disability Index;Immunogenicity;safety data; | — |
Countries
China
Contacts
Public ContactLan Gong
Eye & ENT hospital of Fudan University
Outcome results
None listed