CTRI/2023/10/058660已完成2 期
A phase 2, proof-of-concept, placebo controlled, randomized, multi-centre, double blind study of ZYIL1 to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics in patients with Amyotrophic Lateral Sclerosis (ALS)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 9
- 主要终点
- To measure the efficacy of the treatment using the slope of progression with the revised
研究概览
简要总结
ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with ALS.
This is a proof-of-concept, placebo controlled, randomized, double blind study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Amyotrophic Lateral Sclerosis following a twice daily oral administration of ZYIL1 or matching placebo. Twenty-four (24) patients will be randomly assigned in a 1:1:1:1 ratio to oral twice daily capsules of ZYIL1 25 mg or ZYIL1 50 mg or ZYIL1 75 mg or matching placebo. Patients on ZYIL1 25 mg and 50 mg arm along with matching placebo will be randomized first. Treatment duration will be twelve (12) weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and/or female patients aged between 18 and 80 years (inclusive at screening).
- •Diagnosis of probable or definite ALS, according to the revised version of the El Escorial World Federation of Neurology criteria. Refer Appendix III.
- •El Escorial Criteria.
- •Time since onset# of first symptom of ALS ≤9 months
- •Slow Vital Capacity (SVC) ≥ 50% of the predicted value
- •Be able to swallow the study capsules during study
- •Either not currently receiving riluzole or on a stable dose of riluzole for at least 4 weeks before the screening visit. Participants receiving riluzole are expected to remain on the same dose throughout the duration of the study
- •Either not currently receiving edaravone or on edaravone treatment. Participants receiving edaravone must have completed at least 1 cycle of treatment before the screening visit and are expected to continue with stable dose edaravone treatment throughout the duration of the study.
排除标准
- •With significant cognitive impairment, psychiatric disease, other neurodegenerative disorder (e.g., Parkinson disease or AD), substance abuse other causes of neuromuscular weakness, or any other condition that would make the participants unsuitable for participating in the study or could interfere with assessment or completing the study in the opinion of the Investigator
- •History of recent serious infection (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with IV antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the Investigator’s judgment
- •With active herpes zoster infection within 2 months prior to the screening visit
- •A documented history of attempted suicide within 6 months prior to the screening visit, or in the Investigator’s judgment are at risk for a suicide attempt
- •History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study
- •Participants who are pregnant or are currently breastfeeding
- •A known history of allergy to any ingredients of ZYIL1
- •Patients taking concomitant medicines within 7 days or 5 half-lives of the medication (whichever is longer) prior to first dose of study drug administration till end of the study, which are substrate of CYP1A2 enzymes (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tasimelteon, tizanidine etc.) and CYP2B6 enzymes (e.g., bupropion, efavirenz etc.).
- •Use of any steroids, colchicine or anti-IL-1 inhibitors within 7 days or 5 half-lives of the medication (whichever is longer) prior to first dose of study drug administration.
- •Use of any investigational drugs concurrently or within 4 weeks or 5 half-lives (whichever is longer), prior to first dose of study drug administration.
- •Any clinically significant and/or laboratory significant value or other instability that would prevent the patient from participating in the study as determined by the Investigator.
- •Received a live vaccine within 14 days before the screening visit or planning to receive during the study
- •Participants who have received stem cell or gene therapy for ALS at any time in the past.
结局指标
主要结局
To measure the efficacy of the treatment using the slope of progression with the revised
时间窗: Baseline to Day 84
Amyotrophic Lateral Sclerosis Functional Rating Scale
时间窗: Baseline to Day 84
次要结局
- evaluate effect of ZYIL1 on neurofilament biomarker(Baseline to Day 84)
- safety & tolerability of ZYIL1 in patients with ALS(Baseline to Day 84)
- evaluate pharmacokinetics of ZYIL1(Baseline to Day 84)
研究者
研究点 (9)
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