Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Objectively Measured Percentage Salivary Weight
研究概览
简要总结
This study is being conducted this study to determine whether injections of Xeomin®, a type of botulinum toxin into the glands that produce saliva (one pair just below and in front of the ear and the other just under the jaw line) are safe and effective to treat excessive saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.
详细描述
Participants will be recruited if they have Parkinson's disease, Parkinsonism. Inclusion and exclusion criteria are summarized below. Participants will be screened at the first visit to make sure they are eligible for the trial. They will then undergo baseline testing including neurologic evaluation, questions to assess their memory and cognitive status and evaluation of their disease status using parts of the Unified Parkinsons's Disease Ratings Scale (UPDRS) that are routinely used to follow disease progression. They will be given a questionnaire to evaluate the severity of their drooling. Their saliva production will be measured by having them spit into a cup for 5 minutes, twice.
At the first visit, after making sure they are eligible for the study and performing the baseline testing and procedures, they will be given either Xeomin or placebo (saline injections without medication) injections in the 4 glands that produce saliva. They will not know which injection they received. This visit will take about 2 hours. They will be followed up every month and asked about side effects, have neurologic evaluation and UPDRS testing and fill-in the questionnaire for drooling severity. Saliva volume will be measured as done at the first visit. At either Month 4 or 5, participants will receive the second injection. This will be a "cross-over" injection, i.e., if they received Xeomin at the first injection they will receive saline at the second and vice versa. Thus, all participants will receive the study medication Xeomin, either as the first injection or the second injection at 4 months or 5 months. The follow up after the second injection will be one monthly visit for 3 months, with similar evaluations as described above. The follow-up visit will take about 1 hour each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For PD/ Parkinsonism:
- •PD, Multiple Systems Atrophy (MSA), or Progressive Supranuclear Palsy (PSP) diagnosed by clinical criteria, ages 20-80 with troublesome sialorrhea as defined below**.
- •Sialorrhea that patients or their families or treating physicians think is troublesome
- •Swallowing function: Functional Oral Intake Scale (FOIS)* of 5 or greater
- •If patients have been treated with other medications for sialorrhea earlier, they should be off the medications at least 4 weeks prior to the baseline evaluation.
- •If they are on other medications for sialorrhea at the time of the baseline evaluation, the doses will be held stable throughout the period of the study.
- •Women of child bearing age will need to be on a reliable method of birth control for the duration of the study.
排除标准
- •Current use of Coumadin
- •Concurrent significant medical illness
- •History of myasthenia gravis or Lambert-Eaton Syndrome
- •Ongoing substance abuse
- •History of unreliable follow-up
- •Past use of Xeomin® or other botulinum toxin preparations
- •Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam
研究组 & 干预措施
Incobotulinum Toxin A
Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks
干预措施: Incobotulinum Toxin A (Drug)
Placebo
Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
干预措施: Placebo (Drug)
结局指标
主要结局
Objectively Measured Percentage Salivary Weight
时间窗: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Objectively Measured Salivary Weight
时间窗: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
次要结局
- Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.(baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period)
- Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.(between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period)
- Change in Drooling Frequency and Severity Scale (DFSS) Scores(baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period)
研究者
Pushpa Narayanaswami
Associate Professor of Neurology
Beth Israel Deaconess Medical Center