A Phase IV, Prospective, Open Label, Multi-centre, Single arm, Post market surveillance study to confirm the safety and efficacy of Intraglandular Injection of Xeomin (Clostridium Botulinum neurotoxin type A) in the Management of Sialorrhea in Various Neurological Conditions in the Indian adult population.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 5
- 主要终点
- The change from baseline will be analyzed using a repeated measure analysis of variance model. The summary statistics will include n, mean, median, standard deviation, minimum and maximum.
研究概览
简要总结
The primary goal of this study is to evaluate the safety of injecting XEOMIN (a form of botulinum toxin type A) directly into the salivary glands to treat excessive drooling (sialorrhea) in Indian adults with neurological conditions. Safety will be measured by tracking any adverse events, including treatment-related and serious side effects, throughout the study period. Participants who are unable to visit the clinic as scheduled will still be followed up via phone calls to ensure safety monitoring continues.
The secondary goal is to assess how well the treatment works in reducing drooling. This will be evaluated by measuring changes in saliva flow, severity and frequency of drooling, and overall impressions of improvement by both patients and doctors. The study will also track changes in quality of life using standard questionnaires, with assessments taking place at multiple time points: the start of the study, and at weeks 4, 8, and 12.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 80 years.
- •Documented diagnosis of the basic neurological condition associated with sialorrhea in subjects with Parkinson disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration, or progressive supranuclear palsy) or after stroke or traumatic brain injury.
- •A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points with onset at least 6 months before screening.
- •A score of at least 2 points for each item of the DSFS.
- •A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson Disease (mROMP) (Section III Drooling, Item A) at screening and baseline.
- •No clinically relevant dysphagia mROMP Swallowing Symptoms Item A score is equal to or less than 2 and is equal to or less than 3 on Item C at screening and baseline.
- •No infection or inflammation in the planned injection sites.
- •Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- •Subject willing and able to comply with the study protocol.
排除标准
- •Non-neurological secondary causes of sialorrhea.
- •Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the study.
- •Recent (i.e., four weeks) drug treatment for sialorrhea.
- •History of recurrent aspiration pneumonia.
- •Extremely poor dental/oral condition as assessed by a qualified dentist.
- •Recent treatment with known hypersensitivity to Botulinum toxin or known hypersensitivity to any ingredient of the study preparation.
- •(If the patient has received treatment within a year for sialorrhea or within 14 weeks for other indications)
- •Recent (i.e., four weeks) changes in anti-parkinsonian medication.
- •Previous or planned surgery or irradiation to control sialorrhea.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
结局指标
主要结局
The change from baseline will be analyzed using a repeated measure analysis of variance model. The summary statistics will include n, mean, median, standard deviation, minimum and maximum.
时间窗: 1. Change in Unstimulated Salivary Flow (uSFR) Rate at baseline and Week 4, 8 and 12. | 2. Patients and Investigators Global Impression of Change Scale (GICS) at Baseline, Week 4, 8 and 12. | 3. Drooling severity and Frequency Scale scores (DSFS) from screening, baseline, week 4, 8 and 12. | 4. Changes in EQ-5D-3L quality of life Questionnaire from screening, baseline, week 4, 8 and 12.
Incidence of AEs, Incidence rates of TEAEs and SAEs. Numbers of AEs, SAEs, TEAEs will be tabulated using available version of MedDRA, preferred term, system organ class, severity and relationship. Multiple occurrences of an adverse event will be counted once in that group.
时间窗: 1. Change in Unstimulated Salivary Flow (uSFR) Rate at baseline and Week 4, 8 and 12. | 2. Patients and Investigators Global Impression of Change Scale (GICS) at Baseline, Week 4, 8 and 12. | 3. Drooling severity and Frequency Scale scores (DSFS) from screening, baseline, week 4, 8 and 12. | 4. Changes in EQ-5D-3L quality of life Questionnaire from screening, baseline, week 4, 8 and 12.
次要结局
- To assess the efficacy of Intra-glandular injection of XEOMIN (Clostridium Botulinum neurotoxin type A) in the management of sialorrhea in Indian adult population.(1. Change in Unstimulated Salivary Flow (uSFR) Rate at baseline and Week 4, 8 and 12. (Appendix B))
研究者
Dr Veena RM
CliniExperts Research Services Pvt. Ltd.