NCT04937530Unknown2 期
A Randomized, Double-blind, Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Progressive Supranuclear Palsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in the PSPRS-28 at 48 weeks for the RT001 treated group vs placebo-treated group
研究概览
简要总结
This is a randomized, placebo-controlled trial of RT001 in patients with PSP.
详细描述
This is a randomized, placebo-controlled trial of RT001 in patients with PSP to assess the efficacy, safety and tolerability of RT001. Subjects will be randomized to RT001 or placebo and will receive study drug for 48 weeks.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form prior to entry into the study
- •Male or female subject with age 40 years to 80 years at the time of signed consent
- •Meets the MDS-PSP study group criteria for possible or probable progressive supranuclear palsy with Richardson syndrome (postural instability and falls with vertical ocular motor dysfunction)
- •Presence of PSP symptoms for less than 4 years
- •Score of <40 on the PSPRS-28
- •Ambulatory patients (with or without assistive device - no handheld help) and capable of performing study assessments/evaluations
- •Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) who can assist in assuring that the subject is able to travel to the required visits.
- •Willing to provide the necessary blood samples
排除标准
- •Received treatment with other experimental therapies within the last 30 days prior to the first dose. The last dose of the prior experimental agent must have occurred more than 5 half-lives prior to enrollment in the current trial.
- •Previously received treatment with RT001
- •Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening/Baseline till last study procedure completed)
- •Mini mental state examination (MMSE) score less than 20 at screening
- •Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
- •Evidence of any clinically significant neurological disorder other than PSP in particular CBS
- •Evidence of a clear and robust benefit from levodopa at the time of screening. Participants are permitted to take levodopa and other Parkinson's medications if the dose had been stable for 60 days prior to screening
- •The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria
- •Subject has had a significant illness or infection requiring medical intervention in the past 30 days
- •Subject has evidence of any disease or condition (based on either history, physical or laboratory values) that might interfere with the conduct of the study
- •Is currently receiving active deep brain stimulation (DBS) that cannot be turned off
- •Any condition with a life expectancy of less than 2 years
- •Female who is breastfeeding or has a positive pregnancy test
- •Male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a highly effective birth control method throughout the study
- •Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled
- •History, within the last 2 years, of alcohol abuse or physical opioid dependence
研究组 & 干预措施
RT001
Experimental
RT001 960 mg capsule. 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.
干预措施: RT001 (Drug)
Placebo
Placebo Comparator
Inactive comparator capsule 960 mg (safflower oil). 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the PSPRS-28 at 48 weeks for the RT001 treated group vs placebo-treated group
时间窗: 48 weeks
The PSPRS-28 is a clinician-rated instrument to assess disability and severity of PSP. The PSPRS-28 evaluates 28 items in six categories: daily activities (by history), behavior, bulbar, ocular motor, limb motor and gait/midline.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)COVID-19NCT04352608Sinovac Research and Development Co., Ltd.744
已完成
2 期
RT001 in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT04762589Biojiva LLC43
已完成
2 期
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 ParticipantsCovid19NCT04914377Novatek Pharmaceuticals55
已完成
1 期
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19COVID-19NCT04551547Sinovac Research and Development Co., Ltd.552
已完成
2 期
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive DisorderMajor Depressive DisorderNCT04969510Praxis Precision Medicines110