A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 108
- 主要终点
- For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).
A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.
Another secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
详细描述
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
- •is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
- •Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits
- •Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods
- •Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods
- •Additional criteria apply; please contact the investigator for more information
排除标准
- •has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
- •has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening
- •has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
- •is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
- •has a known hypersensitivity to any components of the IMP
- •is of a vulnerable population (eg, people kept in detention or jail)
- •participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study
- •Additional criteria apply; please contact the investigator for more information
研究组 & 干预措施
TEV-56286
Orally administered capsules once daily
干预措施: TEV-56286 (Drug)
Placebo
Orally administered capsules once daily
干预措施: Placebo (Drug)
结局指标
主要结局
For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
时间窗: Baseline to Week 48
The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).
For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined
时间窗: Baseline to Week 48
The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).
次要结局
- Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)(Baseline to Week 48)
- Change From Baseline in the Pons volume measured by MRI(Baseline to Week 48)
- Change From Baseline in the Cerebellar volume measured by MRI(Baseline to Week 48)
- Change From Baseline in the UMSARS part II score(Baseline to Week 48)
- Change From Baseline in the UMSARS part IV score(Baseline to Week 48)
- Change From Baseline in the Two-minute walk test as part of gait assessment(Baseline to Week 48)
- Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score(Baseline to Week 48)
- Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)(Up to Week 48)
- Number of Participants Who Withdraw From the Study Due to an Adverse Event(Up to Week 48)
- Number of Participants Who Withdraw From Treatment Due to an Adverse Event(Up to Week 48)
- Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value(Up to Week 48)
- Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value(Up to Week 48)
- Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings(Up to Week 48)
- For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)(Baseline to Week 48)
- For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)(Baseline to Week 48)
- Change From Baseline in the UMSARS Part 1 Score(Baseline to Week 48)
- Change From Baseline in Lateral Ventricle Volume Measured by MRI(Baseline to Week 48)
- Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S)(Baseline to Week 48)
- Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)(Baseline to Week 48)
研究者
Medical Information
Scientific
Teva Branded Pharmaceutical Products R&D Inc.