NCT05387798撤回3 期
A Phase 3, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Assess the safety of RAD011 by evaluating the incidence and severity of adverse events reported
研究概览
简要总结
This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015.
The primary objective of this study is to assess the long-term safety and tolerability of RAD011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a parent/legal guardian that is able to consent for their participation. Parent/caregiver/legal guardian can complete the required assessments throughout the study. Patient Consent/Assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent;
- •Patient completed treatment on the SCOUT-015 study through Visit 14 (Week 34);
- •If female, is either not of childbearing potential (defined as premenarchal or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of
- •RAD011 or placebo:
排除标准
- •Significant acute condition (active infection, uncontrolled diabetes, any other uncontrolled chronic condition) including but not limited to clinically significant laboratory abnormality, or medical or psychosocial condition that may preclude the patient from participating in the study, at the Investigator's discretion;
- •Positive urine test for drugs of abuse, including tetrahydrocannabinol (THC), or known history of drug, alcohol, or substance abuse;
- •Significant risk of committing suicide based on history, psychiatric examination, or based on the Investigator's judgment;
- •Significant non-compliance issues (IP misuse or abuse, study visit participation, etc.) during the patient's SCOUT-015 participation based on the Investigator's judgement.
- •Pregnant (determined by a positive urine pregnancy test) or lactating female;
- •Concurrent participation in any other interventional study involving an investigational product, gene therapy, or device.
研究组 & 干预措施
RAD011
Experimental
干预措施: RAD011 (Drug)
结局指标
主要结局
Assess the safety of RAD011 by evaluating the incidence and severity of adverse events reported
时间窗: Baseline through Week 52
Safety analyses will be conducted in all subjects who receive at least one dose of RAD011
次要结局
未报告次要终点
研究者
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