jRCT2080222708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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Change in the 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
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 30age old over 至 79age old under（—）
- 性别
- All
入选标准
- •The participant has a diagnosis of Parkinson's disease with at least two of the following signs: resting tremor, akinesia/hypokinesia, 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 >=
- •The participant has Modified Hoehn & Yahr stage 1 to
- •The participant has the Parkinson's disease diagnosed within 5 years.
- •The participant is an outpatient of either sex aged >= 30 and < 80 years
排除标准
- •The participant has unstable systemic disease.
- •The participant has Mini-Mental State Examination (MMSE) score of <=
- •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 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 received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
- •The participant has received transcranial magnetic stimulation within 6 months.
- •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
- •The participant has received a levodopa-containing product, dopamine agonist, amantadine or anticholinergic drug within 30 days.
- •The participant has received any psychoneurotic agent or antiemetic medication of dopamine agonist within 14 days. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days 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 excluded medications or treatments.
- •The participant whose diagonosis of Parkinson's disease is ruled out by elective dopamine transporter scintigraphy.
- •The participant has laboratory data meeting any of the following at the start:
- •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 excludeded medications or treatments.
结局指标
主要结局
Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score
时间窗: Up to Weeks 28
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
次要结局
未报告次要终点
研究者
研究点 (1)
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