EUCTR2020-003911-90-HU进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be enrolled into the study subjects must meet the following requirements:
- •1. Sign the informed consent form prior to entry into the study
- •2. Male or female subject with age 40 years to 80 years at the time of signed consent
- •3. Meets the MDS-PSP study group criteria for possible or probable PSP with Richardson Syndrome (postural instability and falls with vertical ocular motor dysfunction)
- •4. Presence of PSP symptoms for less than 4 years
- •5. Scoring of < 40 on the PSPRS-28
- •6. Ambulatory patients (with or without assistive device – no handheld help) and capable of performing study assessments/evaluations
- •7. 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.
- •8. Willing to provide the necessary repeated blood samples.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Subjects meeting one or more of the following may not enter the study:
- •1. 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.
- •2. Previously received treatment with RT001
- •3. Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening/Baseline till last study procedure completed)
- •4. MMSE score less than 20 at screening
- •5. Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
- •6. Evidence of any clinically significant neurological disorder other than PSP in particular CBS
- •7. 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
- •8. The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria
- •9. Subject has had a significant illness or infection requiring medical intervention in the past 30 days
- •10. 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
- •11. Is currently receiving active deep brain stimulation (DBS) that cannot be turned off
- •11. Any condition with a life expectancy of less than 2 years
- •12. Female who is breastfeeding or has a positive pregnancy test
- •13. 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
- •14. 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
- •15. History, within the last 2 years, of alcohol abuse or physical opioid dependence.
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