EUCTR2020-003962-38-NL进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
- •1. Male or female subject with age 20 years to 75 years at the time of signed consent for double-blind part of the study
- •2. Patients who are defined as definite ALS, probable ALS or probable-laboratory-supported ALS, met diagnostic criteria revised EL Escorial for Airlie House.
- •3. ALSFRS > 20
- •4. Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
- •5. Patients of less than 3 years after the onset of ALS.
- •6. Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)
- •7. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Received treatment with other experimental therapies within the last 30 days prior to the first dose (for double-blind part of the study only)
- •2. Previously received treatment with RT001 (for double-blind part of the study only)
- •3. Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening till last study procedure completed)
- •4. SVC < 70 at screening
- •5. Subject has a feeding tube or the need for a feeding tube is anticipated within the first 6 months after enrollment.
- •6. Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
- •7. Evidence of any clinically significant neurological disorder other than ALS
- •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. The subject has a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function
- •10. Subject has had a significant illness or infection requiring medical intervention in the past 30 days (for double-blind part of the study only)
- •11. Female who is breastfeeding or has a positive pregnancy test
- •12. Male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective birth control method throughout the study
- •13. 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
- •14. History, within the last 2 years, of alcohol abuse or physical opioid dependence
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