NCT02337725已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa
Takeda0 个研究点目标入组 244 人开始时间: 2015年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 主要终点
- Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to evaluate the efficacy and safety of TVP-1012 in Japanese participants with early Parkinson's disease.
The study period consisted of a 28-week trial period. The participants who fulfill the inclusion criteria and not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1 ratio to either the 1 mg of TVP-1012 or the placebo group. In each treatment group, participants received either 1 mg of TVP-1012 or placebo once daily in a double-blinded manner.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Run-in period
- •In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- •The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •The participant has a diagnosis of Parkinson's disease with at least two of the following signs: resting tremor, akinesia/bradykinesia, and muscle rigidity.
- •The participant has a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score of >=14 at the start of the run-in period.
- •The participant has Modified Hoehn & Yahr stage 1 to 3 at the start of the run-in period.
- •The participant has the Parkinson's disease diagnosed within 5 years prior to the start of the run-in period.
- •The participant is an outpatient of either sex aged >= 30 and < 80 years.
- •A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to 1 month after the last dose of the investigational drug.
- •Treatment period
- •The participant has a MDS-UPDRS Part II + Part III total score of >= 14 at baseline.
排除标准
- •Run-in period
- •The participant has received any investigational medication within 90 days prior to the start of the run-in period.
- •The participant has received TVP-1012 in the past.
- •The participant is study site employee, an immediate family member, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
- •Participant has donated 400 mL or more of his or her blood volume within 90 days prior to the start of the run-in period.
- •The participant has unstable systemic disease.
- •The participant has Mini-Mental State Examination (MMSE) score of <= 24 at the start of the run-in period.
- •The participant has known or a history of schizophrenia, major or severe depression, or any other clinically significant psychiatric disease.
- •The participant has a history of hypersensitivity or allergies to TVP-1012 (including any associated excipients) or selegiline.
- •The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food (e.g., cheese, lever, herring, yeast, horsebean, banana, beer or wine).
- •The participant has a history or concurrent of drug abuse or alcohol dependence.
- •The participant has received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
- •The participant has received transcranial magnetic stimulation within 6 months prior to the start of the run-in period
- •The participant has received amantadine or anticholinergic medication for >= 180 days.
- •The participant has received selegiline, a levodopa-containing product or dopamine agonist for >= 90 days.
- •The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days prior to the start of the run-in period.
- •The participant has received a levodopa-containing product, dopamine agonist, amantadine or anticholinergic drug within 30 days prior to the start of the run-in period.
- •The participant has received any psychoneurotic agent or antiemetic medication of dopamine antagonist within 14 days prior to the start of the run-in period. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days prior to the start of the run-in period may be included in the study.
- •The participant has previously received a catechol-O-methyltransferase (COMT) inhibitor, droxidopa, zonisamide or istradefylline.
- •The participant is required to take any of the prohibited concomitant medications or treatments.
- •If female, the participant is pregnant or lactating or intending to become pregnant during this study, or within 1 month after the last dose of the investigational drug; or intending to donate ova during such time period.
- •The participant has clinically significant neurologic, cardiovascular, pulmonary, hepatic (including mild cirrhosis), renal, metabolic, gastrointestinal, urological, endocrine, or hematological disease.
- •The participant has clinically significant or unstable brain or cardiovascular disease, such as:
- •clinically significant arrhythmia or cardiac valvulopathy,
- •cardiac arrest of NYHA Class II or higher,
- •concurrent or a history of ischemic cardiac disease within 6 months prior to the start of the run-in period,
- •concurrent or a history of clinically significant cerebrovascular disease within 6 months prior to the start of the run-in period,
- •sever hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher),
- •clinically significant orthostatic hypotension (including those with systolic pressure decrease of 30 mmHg or more following postural change from supine/sitting position to standing position),
- •a history of syncope due to hypotension within 2 years prior to the start of the run-in period.
- •The participant is required surgery or hospitalization for surgery during the study period
- •Participant has a history of cancer within 5 years prior to the start of the run-in period, except cervix carcinoma in situ which has completely cured.
- •The participant has acquired immunodeficiency syndrome (AIDS) [including human immunodeficiency virus (HIV) carrier], or hepatitis [including viral hepatitis carrier such as hepatitis B surface (HBs) antigen or hepatitis C antibody (HCV) positive]. However, the participant who has a negative result for HCV antigen or HCV-RNA can be included in the study.
- •The participant who, in the opinion of the investigator or sub-investigator, is unsuitable for any other reason.
- •Treatment period
- •The participant whose diagonosis of Parkinson's disease is ruled out by dopamine transporter scintigraphy performed during the run-in period if conducted.
- •The participant has laboratory data meeting any of the following at the start of the run-in period:
- •Creatinine >= 2 x upper limit of normal (ULN)
- •Total bilirubin >= 2 x ULN
- •ALT or AST >= 1.5 x ULN
- •ALP >= 3 x ULN
- •The participant has received any of the prohibited concomitant medications or treatments during the run-in period.
研究组 & 干预措施
TVP-1012 1 mg
Experimental
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
干预措施: TVP-1012 (Drug)
Placebo
Placebo Comparator
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
时间窗: From Baseline to Week 26 (LOCF)
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II+III Total Score was 0-188, with higher scores reflecting greater severity.
次要结局
- Number of Participants With TEAE Related to Body Weight(Up to Week 26)
- Change From Baseline in MDS-UPDRS Part I Total Score(Baseline and Week 26 (LOCF))
- Number of Participants With Markedly Abnormal Vital Signs Values(Up to Week 26)
- Number of Participants With TEAE Related to Electrocardiograms (ECG)(Up to Week 26)
- Change From Baseline in MDS-UPDRS Part II Total Score(Baseline and Week 26 (LOCF))
- Change From Baseline in MDS-UPDRS Part III Total Score(Baseline and Week 26 (LOCF))
- Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to Week 26)
- Number of Participants With TEAE Related to Clinical Laboratory Tests(Up to Week 26)
研究者
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