A Phase 2 Study to Evaluate the Safety, Tolerability and Initial Efficacy of Pramipexole ER, Given With Aprepitant in Patients With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with change in weight
研究概览
简要总结
A Phase 2 study to evaluate the safety, tolerability and initial efficacy of pramipexole ER, given with aprepitant in patients with parkinsonian type disorders
详细描述
Methodology:
This is an initial Phase 2, rising-dose, single-blind, out-patient, sequential-treatment study in up to 24 patients with idiopathic Parkinson's disease of about 5 months duration. All participants will have idiopathic Parkinson's disease (PD).
Subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments.
The study will be conducted in three parts:
Part 1: All eligible patients switch from their dopaminergic treatment to the equivalent dose of pramipexole ER in the judgement of the investigator. Then, pramipexole ER is titrated alone up to the patients' optimal dose or to the protocol maximum allowed dose for Part 1 of 4.5 mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate eligibility of the study.
- •Males and females aged 40 - 80 years inclusive.
- •Meet criteria for the diagnosis of possible/ probable idiopathic Parkinson's disease (PD; Postuma RB, et al. 2015)
- •Have not previously been treated with CD/LD.
- •PD severity in the Hoehn & Yahr 2 to 3 range.
排除标准
- •Women who are pregnant or may become pregnant.
- •Nursing mothers.
- •Individuals who have taken a study medication (pramipexole and/or aprepitant) within 3 months of study admission.
- •Moderate and severe renal impairment (Creatinine Clearance: < 60 mL/min calculated by Cockcroft and Gault equation)
- •Severe hepatic impairment (Child-Pugh C)
- •Hypersensitivity to any component of either study medication
- •Being treated with the following medications:
- •Pramipexole
- •Centrally acting dopamine antagonists during preceding month
- •Strong CYP3A4 inducer or inhibitor
- •Warfarin (a CYP2C9 substrate)
- •Hormonal contraceptives
- •Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
- •Patients who have any clinically significant hypotension or ECG abnormality.
- •Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- •Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
研究组 & 干预措施
CTC-413
Pramipexole with/with out aprepitant orally once daily
干预措施: CTC-413 (Combination Product)
结局指标
主要结局
Number of participants with change in weight
时间窗: mulitple times from baseline through Month 3
Number of participants with a change in weight (either by pounds or kilograms) from baseline
Number of participants with change in in physical examine
时间窗: multiple times for the duration of the study (baseline through Month 3)
physical examination changes General appearance,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
时间窗: multiple times for the duration of the study (baseline through Month 3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
Number of participants with change in in clinical laboratory evaluations
时间窗: multiple times for the duration of the study (baseline through Month 3)
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
Number of participants with change in Electrocardiography (ECG)
时间窗: multiple times for the duration of the study (baseline through Month 3)
ECG (standard digital 12-lead in singlicate).
次要结局
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(multiple times from baseline through Month 3)
- Pharmacokinetics of pramipexole and aprepitant(multiple times from baseline through Month 3)
- modified Columbia-Suicide Severity Rating Scale(multiple times from baseline through Month 3)