An Early Phase 1 interventional study of Botulinum toxin type A in Blepharospasm, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Early Phase 1, Interventional, and Treatment
Blepharospasm (BSP) is a chronic, idiopathic, recurrent and progressive disease, which mostly occurs in both eyes. It is mainly manifested as involuntary spasm of muscles around the eyes, leading to uncontrollable narrowing or even closure of blepharospasm. Although there is no pain in BSP patients, it can cause social or psychological dysfunction, make patients feel difficult in driving, reading and working, and seriously affect the social, work and life of patients.
Depression and anxiety are common and harmful mental disorders. At present, less than 40% of patients with depression can get effective treatment. Using simple and effective screening tools can effectively improve the detection rate of depression, so that patients can get timely and effective treatment. It is also an effective measure to prevent suicide.
Botulinum toxin type A (BTX-A) has achieved gratifying results in the treatment of dyskinesia. It has been confirmed that BTX-A has a significant effect on BSP. The effective rate is 70% - 90%. About 50% of the patients can regain normal or near normal visual function. At present, no prospective studies have explored this association between blepharospasm and depression / anxiety, and whether BTX-A can improve this mood disorder. Therefore, our research goal is to further study the relationship between blepharospasm and depression / anxiety, sleep in a prospective way, and to determine whether BTX-A treatment will affect depression / anxiety symptoms, so as to provide more theoretical basis for clinical treatment.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients were treated with Botulinum toxin type A
Drug: Botulinum toxin type A
Patients were treated with Botulinum toxin type A applications on the Orbicularis oculi and glabellar complex
Change from baseline blepharospasm evaluation at 3 months
Patients will evaluated the Jankovic Rating scale (JRS)，the total score of JRS is 8, and a change of 2 points in the JRS is clinically meaningful.
Time frame: Through study completion, 3 months.
Change from baseline depression evaluation at 3 months
Patients will evaluated the personal Health Questionnaire Depression Scale (PHQ-8) with a total score of 24, cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of depressive symptoms.
Time frame: Through study completion, 3 months.
Change from baseline anxiety evaluation at 3 months
Patients will evaluated the Generalized Anxiety Disorder 7-item scale (GAD-7) questionnaires with a total score of 21, cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety symptoms.
Time frame: Through study completion, 3 months.
Change from baseline sleep disorders evaluation at 3 months
Patients will evaluated the Athens insomnia scale (AIS) questionnaires, the severity criteria of the AIS are capable of categorizing insomnia severity as follows: absence of insomnia (0-5), mild insomnia (6-9), moderate insomnia (10-15), and severe insomnia (16-24).
Time frame: Through study completion, 3 months.
Plan to share: Undecided
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Second Affiliated Hospital, School of Medicine, Zhejiang University →