NCT02382198Unknown2 期
A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva.
研究概览
简要总结
Sialorrhea is a frequently occurring problem with detrimental effect on quality of life in 25% of PD patients. Currently, there is no intervention approved for sialorrhea in Parkinsons and evidence is only available for a 30-day effect or less. We hypothesize that glycopyrrolate will have a lasting effect in the reduction of sialorrhea in PD patients.
详细描述
To assses if Glycopyrrolate has a long lasting effect on sialorrhea for patients with Parkinsons.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD as defined by United Kingdom PD Society Brain Bank criteria
- •Moderate-to-severe sialorrhea defined by a score in the item 2.2 of the MDS-UPDRS greater than 2
排除标准
- •Other idiopathic parkinsonian syndromes, e.g., Progressive Supranuclear Palsy, Cortico-basal syndrome, or Multiple System Atrophy
- •Secondary parkinsonian syndromes (drug-induced, traumatic, encephalitic or vascular)
- •Change in antiparkinsonian medication one month prior to enrolment
- •Prior use of glycopyrrolate with or without known hypersensitivity will be considered an exclusion criterion, as it increases the risk of unblinding due to prior knowledge of potential side effects or therapeutic benefit
- •Change in the dose one month prior to enrolment of other anticholinergic agents or other drugs potentially affecting saliva production, such as tricyclic antidepressants, MAO-A inhibitors, neuroleptics (including clozapine and quetiapine more frequently used in PD) or hypnotics. These medication will remain in a constant dose throughout the trial;
- •Concomitant use of solid oral dosage forms of potassium chloride;
- •Pregnancy, breastfeeding, and premenopausal females or males not using adequate contraception; medically acceptable birth control methods for this study include: (1) Abstinence (no sexual intercourse); (2) Intrauterine device (IUD); (3) Diaphragm with spermicide; (4) Condom with spermicide; and (5) Oral contraceptives (birth control pills) + condom/diaphragm with spermicide.
- •Moderate-to-severe constipation in spite of optimal treatment (MDS-UPDRS, item 1.11>2);
- •Conditions that preclude anticholinergic therapy, e.g., documented history or symptoms suggestive of inflammatory bowel disease, glaucoma, myasthenia gravis, prostatic hypertrophy or obstructive urinary symptoms;
- •Conditions that can be exacerbated by anticholinergic effects of glycopyrrolate, e.g., documented history or symptoms suggestive of congestive heart failure, coronary heart disease, gastro-esophageal reflux disease or hyperthyroidism;
- •Uncontrolled arterial hypertension (TAS>140 mmHg or TAD>90 mmHg, using an electronic sphygmomanometer and standardized procedure16);
- •Tachyarrhythmia (interval RR <0.6 sec.);
- •TSH<0.4 mIU/L;
- •Liver dysfunction (AST, ALT, ALP >2xUpper Normal Limit);
- •Renal dysfunction (creatinine clearance <50 mL/min), as glycopyrrolate has predominant renal clearance;
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent;
- •Clinical significant lactose intolerance or known hypersensitivity to any of the study medication excipients
- •Participation in another investigational study at the time of recruitment or during the prior month.
研究组 & 干预措施
Active Group
Active Comparator
This arm will receive the study drug glycopyrrolate.
干预措施: Glycopyrrolate (Drug)
Placebo Group
Placebo Comparator
Control arm to receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva.
时间窗: 90 days
次要结局
- Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale(90 days)
- Proportion of participants with a reduction of severity of sialorrhea in at least one point from baseline to end of treatment (day 90), measured by the MDS-UPDRS, item 2.2.(90 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Testing the Effectiveness of Henna on Managing PPEPalmar-plantar Erythrodysesthesia (PPE)NCT01751893Cyprus University of Technology56
已完成
1 期
Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back PainChronic Low Back PainDegenerative Disc DiseaseNCT04849429Dr. Himanshu Bansal Foundation30
已完成
不适用
Pre-biotics and Probiotics for Constipation in Parkinson's DiseaseConstipationNCT02459717Emanuele Cereda120
已完成
4 期
Balneum Plus cream for the treatment of itchy skin in renal patientsraemic pruritus in adult haemodialysis patients.Skin and Connective Tissue DiseasesUraemic pruritusISRCTN13971661Portsmouth Hospitals NHS Trust58
Unknown
4 期
Pregabalin for the Treatment of Uremic PruritusUremic PruritusNCT01852318National Taiwan University Hospital210