Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 13
- 主要终点
- Improvement of the functional embarrassment provoked by sialorrhea
研究概览
简要总结
Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.
详细描述
The patient will benefit from an ultrasound guided injection of botulinum toxin A (Botox®) or placebo (NaCl 0.9 %) and will be followed up in consultation at 4, 12, 16 (if reinjection) and 24 weeks. He will be contacted by telephone in 2 and in 8 weeks (percentage of decrease of functional embarrassment, percentage of decrease of salivary secretion rate). He can be able to benefit in the open label phase of a botulinum toxin type A injection at the 12-week follow up if he estimates that first injection was not effective or if the efficiency of the first injection began to become blurred. After the 6 months of the study, the patient will benefit again from the usual follow-up as advised by the French consensus conference in November, 2005.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age > 18 years
- •Obtaining of a written consent after information
- •Diagnosis of probable or certain ALS according to the El Escorial criteria of the World Federation and Neurology Committee on Neuromuscular Diseases
- •Patient having a follow-up in an ALS center
- •Sialorrhea with VAS functional embarrassment > or equal at 50/
- •Patient beneficiary of Social Security regime
排除标准
- •Evolving disease associated with predictable survival < 1 month
- •Patient having previously received an injection of botulinum toxin in the salivary glands
- •Patient taking the other medical treatments for sialorrhea in the 7 days before the inclusion in the study (scopoderm, trihexyph'nidyle, atropine, ipatropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, beta-blockers)
- •Patient having benefited from radiotherapy or from surgery on the salivary glands
- •Behavioral problems, dementia or other psychiatric problems
- •Myasthenia
- •Known Pregnancy or absence of contraception recognized as effective, breast feeding
研究组 & 干预措施
Botox
Botox injection : 100 UI of botulinum toxin type A (Botox®) diluted in 2.2 ml of NaCl 0.9 %
干预措施: Botox injection (Drug)
Placebo
Placebo injection : NaCl 0.9 %
干预措施: Placebo injection (Drug)
结局指标
主要结局
Improvement of the functional embarrassment provoked by sialorrhea
时间窗: 1 month after the injection
Demonstrate after the injection of botulinum toxin type A an improvement of at least 25 % of the functional embarrassment provoked by sialorrhea in the ALS patient, evaluated with a horizontal visual analogue scale (VAS).
次要结局
- Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver(1 month after the injection)
- Improvement of the value of the hypersalivation item in ALSFRS-R scale(1 month after the injection)
- Modification of the speech evaluation(1 month after the injection)
- Description of patient cohort after the first injection(6 months after the injection)
- Decrease of the score of severity and frequency of the drooling rating scale(1 month after the injection)
- Decrease of the cotton roll weight(1 month after the injection)
- Decrease of the number of paper handkerchiefs used(1 month after the injection)
- Improvement of the quality of life(1 month after the injection)