A Double-blind Randomised Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in the amount of saliva produced within 6 months
研究概览
简要总结
The efficacy of Botulinum toxin A (BoNT-A) in Asian population has not been properly studied and there is no literature available on the most efficacious dose of BoNT-A for sialorrhoea treatment. This research is aimed to find the dose of Dysport® that would be efficacious without treatment-related adverse events and the duration of effectiveness of the drug for sialorrhea treatment in Malaysian patients. The efficacy, safety, tolerability and adverse effects of three doses of Dysport®(50MU, 100MU and 200MU) are examined at 2,6,12 and 24 weeks post injection in this double-blinding, randomized trial.
详细描述
Study Objectives:
To determine the efficacy, safety, tolerability and adverse effects of three doses of Dysport® (50MU, 100MU and 200MU) in the treatment of sialorrhoea in Asian patients with neurological disorders/diseases and to determine the most efficacious dose.
Study design:
Dose-ranging double blind pilot study.
Sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old.
- •Patients with neurological disorder including stroke, motor neurone disease, traumatic brain injury and Parkinsonism, diagnosis confirmed clinically by their treating physicians.
- •Patients with a Thomas-Stonell Drooling Frequency and Severity Scale combined drooling ranking of ≥
- •Patients who are able to give signed informed consent and are willing and able to comply with scheduled visits, treatment plan and other study procedure.
排除标准
- •Patients who are pregnant.
- •Patients with bleeding disorders or who are on anticoagulants.
研究组 & 干预措施
Botulinum toxin A (BoNT-A) 50U
Drug dilution and dosage:
- Prepare a mother solution of 500 U/ml by diluting Botulinum toxin A Dysport® with 1 ml of 0.9% saline.
- Prepare in 1 ml syringe to get 50U/ml :0.1 ml drawn from the mother solution and add 0.9 ml of 0,9% saline. Total volume of 1 ml.
Intervention: Botulinum toxin A (BTX-A) 50U are divided equally into 4 salivary glands, 12.5U each gland
干预措施: Botulinum toxin A (BoNT-A) 50U (Drug)
Botulinum toxin A (BoNT-A) 100U
Drug dilution and dosage:
- Prepare a mother solution of 500 U/ml by diluting Botulinum toxin A Dysport® with 1 ml of 0.9% saline. 2. Prepare in 1 ml syringe to get 100U/ml :0.2 ml drawn from the mother solution and add 0.8 ml of 0.9% saline. Total volume of 1 ml.
Intervention: Botulinum toxin A (BTX-A) 100U are divided equally into 4 salivary glands, 25U each gland
干预措施: Botulinum toxin A (BoNT-A) 100U (Drug)
Botulinum toxina A (BoNT-A) 200U
Drug dilution and dosage:
- Prepare a mother solution of 500 U/ml by diluting Botulinum ToxinA Dysport® with 1 ml of 0.9% saline. 2. Prepare in 1 ml syringe to get 200U/ml :0.4 ml is drawn from the mother solution and 0.6ml of 0.9% saline is added. Total volume of 1 ml.
Intervention: Botulinum toxin A (BTX-A) 200U are divided equally into 4 salivary glands, 50U each gland
干预措施: Botulinum toxin A (BoNT-A) 200U (Drug)
结局指标
主要结局
Change from baseline in the amount of saliva produced within 6 months
时间窗: 2,6,12 and 24 weeks post injection
the amount of saliva produced was measured by the differential weight of a dental roll gauze placed in the buccal mucosal cavity calculated via an electronic microbalance scale to the nearest 0.0001 g
次要结局
- subjective report of sialorrhea/ drooling within 6 months post injection(2,6,12 and 24 weeks post injection)
研究者
Mazlina Mazlan
Associate Professor
University of Malaya