NCT05031351Unknown2 期
Nuclear Factor Kappa Beta Inhibition in Patients With Amyotrophic Lateral Sclerosis: A Phase II Randomized Placebo Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (safety)
研究概览
简要总结
This is a Phase II, single centre, randomized, parallel, double blind, placebo-controlled clinical trial to determine the safety of Withania somnifera in participants with Amyotrophic Lateral Sclerosis (ALS).
详细描述
There will be up to 75 participants randomized 1:1:1 to receive either high dosage Withania somnifera extract (1088 mg daily), medium dosage Withania somnifera extract (544 mg daily) or matching placebo. The study will consist of a Screening Period, Randomization visit, Baseline visit, and Follow-up visits. The treatment period will be 8 weeks and a final follow up call will occur at Week 9.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with laboratory supported probable, clinically possible, probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria (83) (Appendix A)
- •Disease duration from symptom onset no greater than 36 months at the Screening Visit
- •Aged 18 years or older
- •Capable of providing informed consent and complying with study procedures
- •If taking riluzole, on a stable dose for at least 30 days prior to Screening Visit
- •If taking edaravone, on a stable dose for at least one cycle prior to Screening Visit
- •If on BiPAP, average usage of no more than 12 hours per day at time of Screening Visit
- •Able to swallow a capsule at Baseline Visit
- •Fluency in English or French
排除标准
- •Exposure to any investigational agent or Withania somnifera (Ashwagandha) within 30 days prior to the Screening Visit; simultaneous participation in other observational studies is allowed upon Site Investigator approval
- •Presence of any of the following clinical conditions:
- •Substance abuse within the past year
- •Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease
- •Acquired Immunodeficiency Syndrome (AIDS) or AIDS-related complex
- •Unstable psychiatric illness defined as psychosis (hallucinations or delusions) or untreated major depression within 90 days prior to the Screening Visit
- •Hypersensitivity or allergy to Withania somnifera
- •Uncontrolled diabetes with severe associated complications (such as neuropathy)
- •Untreated hypertension, active stomach ulcers, or untreated thyroid disorder
- •Previously diagnosed auto-immune condition with or without neurological manifestations (e.g. multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.)
- •Current or planned use of oral, intramuscular or intravenous steroid drugs (such as prednisone, prednisolone, dexamethasone, triamcinolone, methylprednisolone, oxandrolone, and others) or immunosuppressant drugs (azathioprine, mycophenolate, tacrolimus, sirolimus, cyclophosphamide, and others) for more than 7 days
- •Planned consumption of alcohol, other drugs or natural health products with sedative and anxiolytics properties while taking study drugs (8 week duration)
- •Current or planned use of continuous subcutaneous, intravenous or oral anticoagulant drugs
- •Scheduled for surgery under general anesthetic within 14 days of Screening Visit
- •Pregnancy or planned pregnancy. Women of childbearing potential must have a negative pregnancy test and be non-lactating at the Screening Visit
- •Insertion of a diaphragm pacing system
研究组 & 干预措施
High dosage Withania somnifera
Experimental
544mg oral twice a day
干预措施: Withania somnifera (Drug)
Medium dosage Withania somnifera
Experimental
272mg oral twice a day
干预措施: Withania somnifera (Drug)
Placebo
Placebo Comparator
Matched capsules twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (safety)
时间窗: From Baseline visit until end of study visit (Week 9)
Incidence of adverse events
次要结局
- Change in RMT values(Baseline to 8 weeks)
- Change in strength duration time constant(Baseline to 8 weeks)
- Change in recovery cycle(Baseline to 8 weeks)
- Change in SICI values(Baseline to 8 weeks)
研究者
研究点 (1)
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