NCT04201093已完成3 期
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)
AbbVie72 个研究点 分布在 7 个国家目标入组 529 人开始时间: 2019年12月13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
- 529
- 试验地点
- 72
- 主要终点
- Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF)
- •Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment
- •Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
- •Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria
- •Participants with modified Hoehn and Yahr stage 1, 1.5, or 2
- •Participants with disease duration (from time of diagnosis) of less than (<) 3 years and disease progression in the 3 years before signing the ICF
- •Participants with an MDS-UPDRS Part II score >=2 and Part III score >=10 at the Screening Visit and at the Baseline Visit
- •Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management
- •Participants who are treatment naïve or have a history of prior incidental treatment with dopaminergic agents (including Levodopa [L-Dopa] and dopamine receptor agonist medications) for <3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of monoamine oxidase B (MAO-B) inhibitors is permitted if use was initiated >90 days before the Baseline Visit and the dosage will remain stable for the duration of the trial (i.e, no change in the MAO-B inhibitor dose is permitted during the trial)
- •Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
排除标准
- •Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism).
- •Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages.
- •Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
- •Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures.
- •Participants with a history of psychosis or hallucinations within the previous 12 months.
- •Participants who answer "yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
- •Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days)
- •Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial
- •Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding).
- •Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening.
- •Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to [<=] 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control.
- •Participants with a history of neuroleptic malignant syndrome.
- •Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
- •Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product), prescription, or over-the-counter medications or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor
- •Participants with a Montreal Cognitive Assessment (MoCA) score <26
- •Participants with clinically significant orthostatic hypotension (eg, syncope)
- •Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec
- •Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula <30 mL/min or on dialysis)
- •Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary:
- •Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >=3 × Upper Limit Normal (ULN).
- •Total bilirubin >=1.5 × ULN. Participants with a history of Gilbert's syndrome may be eligible provided they have a value <ULN for direct bilirubin.
- •Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results.
研究组 & 干预措施
Tavapadon 5 mg
Experimental
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.
干预措施: Tavapadon (Drug)
Tavapadon 15 mg
Experimental
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
干预措施: Tavapadon (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
时间窗: Week 26
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
次要结局
- Change From Baseline in the MDS-UPDRS Part II Score(Week 26)
- Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on PGIC(Week 26)
- Change From Baseline in the MDS-UPDRS Parts II and III Combined Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
- Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
- Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
- Change From Baseline in the CGI-S Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
- Change From Baseline in the CGI-I Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
- Change From Baseline in the Epworth Sleepiness Scale (ESS)(Week 26)
- Change From Baseline in the PGIC Score(Week 5, 8, 11, 14, 18, 22, 26, and 27)
- Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)(Week 26)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Week 27)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From first dose of study drug until 190 days following last dose of study drug.)
研究者
研究点 (72)
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