CTRI/2025/10/095900招募中3 期
A Randomized Multicentre Open Label Active Controlled Parallel Group Phase III Clinical Study to Evaluate the Efficacy and Safety of Cenobamate Tablets in Comparison with Eslicarbazepine acetate Tablets in Adult Patients suffering from Focal Onset Seizures
M/s MSN Laboratories Private Limited16 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2025年10月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 254
- 试验地点
- 16
- 主要终点
- Percentage change in seizure frequency per 28 days
研究概览
简要总结
This is a Randomized, Multicentre, Open Label, Active Controlled, Parallel Group, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cenobamate Tablets in Comparison with Eslicarbazepine acetate Tablets in Adult Patients suffering from Focal Onset Seizures. Subjects randomized to the test arm will receive Cenobamate tablets once
daily for 18 weeks. Subjects will receive Cenobamate 12.5 mg tablets once
daily for the first 2 weeks. The dose will be up titrated to 25 mg once daily
on week 3, 50 mg once daily on week 5, 100 mg once daily on week 7 and
150 mg once daily on week 9. From week 11 to 16 (Day 77 to 112)
Subjects will receive 200 mg Cenobamate tablets once daily
(maintenance dose). Following this period, the dose will be tapered off.
On week 17 the dose will get down-titrated to 100 mg once daily and after
4 days the dose will get reduced to 50 mg once daily. On week 18 the dose
will get down-titrated to 25 mg once daily and after 4 days the dose will
get reduced to 12.5 mg once daily and then stopped.
Subjects randomized to the comparator arm will receive Eslicarbazepine
400 mg tablets once daily for the first 5 weeks. From Week 6 to Week 10
Subjects will receive Eslicarbazepine 600 mg tablets once daily. From
Week 11 to 18 (Day 77 to 126) Subjects will receive the maintenance dose
of 800 mg Eslicarbazepine tablets once daily.The total study duration is approximately 23 weeks (1 week screening
period, 4 weeks run-in period, 16 weeks treatment period and 2 weeks
tapering period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male or female subjects aged 18 to 65 years at the time of screening 2 Subjects with confirmed diagnosis of focal onset seizures with or without secondary generalization for at least 12 months as defined in the International League Against Epilepsy classification of seizures focal onset seizures may be focal aware motor or focal impaired awareness or focal with secondary tonic clonic generalization 3 Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4 weeks prior to Visit 1 4 Have a minimum of 4 partial onset seizures during the 4 week run in period A caregiver or witness must be with the subject for a sufficient duration to accurately chronicle the occurrence of seizures These seizures must have been documented in the subjects diary 5 Subjects with ability to understand and provide voluntary written informed consent to participate in this clinical investigation and from whom IECIRB approved written informed consent has been obtained 6 Subjects who can understand and comply with the requirements of the study protocol like consuming the medications as instructed returning for the required treatment period visits complying with prohibited medications and be able to complete the study 7 Female Subjects of childbearing potential practicing an acceptable method of birth control such as sexual abstinence intrauterine device or a double barrier method or vaginal spermicidal suppository for the duration of the study and up to 28 days after the last dose of study drug as judged by the investigator study physician and agree to follow the same OR Postmenopausal for at least 1 year OR Surgically sterile bilateral tubal ligation bilateral oophorectomy hysterectomy has been performed on the Subject.
排除标准
- •1 Subjects with Focal seizure without a motor component 2 Subjects with Primary generalised onset or unknown onset seizures 3 Subjects with seizures occurring in clusters 4 Subjects with Lennox Gastaut syndrome absence seizures or with seizures due to an underlying medical illness or metabolic syndrome 5 Subjects with history of Status Epilepticus within 3 months of enrolment 6 Subjects with history of non-epileptic seizures 7 Subjects with progressive neurological disorders including but 8 Subjects with an active CNS infection demyelinating disease neurodegenerative disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of study results 9 Subjects with known allergic reaction or intolerance to Cenobamate Eslicarbazepine Carbamazepine Oxcarbazepine and or any excipients of the study drug 10 History of drug abuse and or alcohol abuse within last 2 years 11 Family history of familial short QT syndrome 12 Subjects with serious psychiatric disorders like Schizophrenia Depression or Bipolar disorder 13 A yes answer to Question 1 or 2 of the CSSRS Suicidal Ideation section for the past 6 months or a yes answer to any of the CSSRS Suicidal Behaviour section question for the past 2 years 14 Subjects operating hazardous machineries including automobiles 15 History of cardiac conditions including myocardial Infarction unstable angina transient ischemic attacks, arrhythmia cerebrovascular accident cardiac surgery or revascularization within 3 months of screening 16 Subjects who had previously failed an adequate trial of Cenobamate 17 History of severe untreated asthma anaphylactic reactions or severe urticaria and or angioedema 18 Any abnormality on 12 lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for subjects participation in the study 19 Subjects with a history of anaemia or haemoglobinopathy And or haemoglobin less than10 g per dL at screening or any bleeding disorder 20 Subjects having uncontrolled HTN with SBP greater than 160 mmHg And or DBP greater than 100 mmHg with or without antihypertensives at screening 21 Subjects with clinically significant renal disorders a eGFR less than 90 mL per min b Serum creatinine levels greater than or equal to1point 5mg per dL 22 Subjects with hypothyroidism or hyperthyroidism 23 Subjects with HbA1C greater than 9 percentage 24 Subjects with known history of HIV Hepatitis B or Hepatitis C 25 Subjects with hepatocellular insufficiency and in Subjects with hepatic failure or active liver disease abnormal Liver Function Test with Total bilirubin more than 1point 5 times the upper limit of normal or ALT AST more than 2 point 5 times the UNL 26 Subjects with signs & symptoms of Covid19 infection 27 Subjects with active or prior severe unstable or uncontrolled respiratory hepatic renal disease immunological or neurological disorders other than focal epilepsy 28 Subjects with any other clinically significant medical condition or laboratory values at screening that might adversely impact the safety of the study participants or confound the study results 29 Subjects who have participated in another investigational study within 90 days prior to screening in this study or planning to participate during the study 30 Active malignancy or history of malignancy 31 Currently taking prohibited concomitant medication which interrupt study medication outcome.
- •32 Subjects with participation in a blood or plasma donation program within 30 days prior to the study intervention administration 33 Suspected inability or unwillingness to comply with the study procedures 34 Subjects otherwise judged to be inappropriate for inclusion in The study by the investigator judgement.
结局指标
主要结局
Percentage change in seizure frequency per 28 days
时间窗: per 28 days from baseline to week 16
次要结局
- 1 Percentage of responders at the end of 16 weeks(2 Proportion of Subjects who have at least 75% reduction in seizure)
研究者
Mr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
研究点 (16)
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