Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
Conditions
Interventions
Intervention1: Cenobamate tablet: Week 1: 1 tablet of 12.5 mg once daily at bedtime
Week 2 : 1 tablet of 25 mg once daily at bedtime
Week 3 & 4: 1 tablet of 50 mg once daily at bedtime
Week 5 & 6: 1 t
Sponsors
Bajaj Healthcare Limited
Ms Bajaj Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 70 years [both inclusive] 2.Gender: Male or female patients 3.All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form 4.A diagnosis of focal seizures according to the International League Against Epilepsy is Classification of Epileptic Seizures (1981).Diagnosis should have been established by clinical history and an electroencephalogram (EEG). 5.Within the 2 months before randomization (baseline period), Subjects are required to have >=3 focal aware (simple) seizures with motor component, including aphasia and other observable symptoms; focal impaired awareness (complex); or focal to bilateral tonic-clonic (secondarily generalized) seizures per month, plus no consecutive 21-day seizure-free period 6.EEG performed within 5 years prior to Visit 1 that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (i.e. clinical history) and/ or there are at least 3 home videos of an ictal event with QOV score of >= 5. For chronic patients for which the current diagnosis is not very clear, additional EEG results older than 5 years but within 10 years may be used for final confirmation of epilepsy diagnosis 7.Need additional antiepileptic drug (AED) treatment despite having been treated with at least one AED with adequately tolerated dose for the last 2 years 8.Currently on stable antiepileptic treatment regimen: 8.1 Subject must have been receiving stable doses of 1 to 3 AEDs for at least 4 weeks prior to Visit 1 to be continued unchanged throughout the double-blind treatment period of titration and maintenance phase. 8.2 Vagal nerve stimulator (VNS) or deep brain stimulator (DBS) will not be counted as an AED; however, the parameters must remain stable for at least 4 weeks prior to Visit 1 and during the study. VNS or DBS must have been implanted at least 5 months prior to Visit 1. 8.3 The daily use of benzodiazepines (except for diazepam) for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED and must be continued unchanged throughout the study. Therefore, only a maximum of 2 additional approved AEDs will be allowed 8.4 Subjects receiving felbamate as a concomitant AED must meet the following criteria: 8.4.1 Two-year history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 8.4.2 No prior or known history of hepatotoxicity or hematologic disorder due to felbamate 9. Computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within the past 5 years that ruled out a progressive cause of epilepsy. If brain imaging has not been performed within the past 5 years, a CT scan must be performed prior to randomization. For chronic patients for which the current diagnosis is not very clear, additional CT or MRI results older than 5 years but within 10 years may be used for final confirmation of epilepsy diagnosis. 10. Ability to reach Subject by telephone. 11.Use of an acceptable form of birth control by female subjects of childbearing potential. 12.Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1 and will remain stable for the duration of the study.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to cenobamate or structurally similar drugs or eslicarbazepine or to any of the excipients of the investigational products. 2.Patients taking vigabatrin within the past year, felbamate for less than 18 continuous months, or intermittent rescue benzodiazepines more than once a month within the past month. 3.Patients taking phenytoin or phenobarbital because of the potential for drug-drug interaction with cenobamate inhibition of CYP2C19. 4.Patients with a history of status epilepticus within the past year. 5.Patients with history of alcoholism or drug abuse within the past 2 years. 6.Patients with clinically significant psychiatric illness. 7.Patient with active suicidal ideation within the past 6 months or history of suicide attempt in the past 2 years. 8.8.Patients with more than 2 allergic reactions to an AED or 1 serious hypersensitivity reaction. 9.Patients with clinically significant impaired hepatic function established by SGOT & SGPT values more than 2.5 times the UNL and/ or Total bilirubin value of more than 1.5 times the UNL. 10.Patients with other clinically laboratory (biochemistry and hematology) evaluations and 12 lead ECG readings outside the reference range of the testing laboratory and the results are deemed clinically significant by the investigator. 11.Patients with history of clinically significant cardiovascular disease (e.g. ischemic heart disease), central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension etc., which are not fit for inclusion in this CT as per investigator. 12.Patient has a clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the trial. 13.Patients with medical history of oncological conditions since last 5 years. 14.Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology. 15.Patients who had suffered from COVID-19 within 8 weeks prior to study drug administration or patients with suspected signs and symptoms of COVID-19/ confirmed novel coronavirus infection (COVID-19) 16.Women of child bearing potential not practicing any acceptable methods of contraception during study. For this study, acceptable and effective methods of contraception for females include at least one of the following: a.Intrauterine device placed at least 6 months prior to the first study dose and agree to follow throughout the study b.Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) c.Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner) d.Females who are surgically sterile e.Females who are post-menopausal for at least one year 17.Pregnant or lactating women 18.Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the trial is to evaluate efficacy i.e. percent change from baseline in focal seizure frequency per 28 days. Seizure frequency during the baseline and 12 week treatment periods and dividing by the total durationTimepoint: Visit 1: Baseline Visit at Day 00 Visit 2: Screening Visit: any time 2 weeks after baseline visit Visit 3: Enrollment Visit: week 4/day 28 Visit 4: Follow up Visit: week 5/day 35 Visit 5: Follow up visit: week 6/day 42 Visit 6: Follow up visit: Week 8/day 56 Visit 7: Follow up visit: Week 10/day 70 Visit 8: Follow up visit: Week 12/day 84 Visit 9: Follow up visit: week 15/day 105 Visit 10: Follow up visit: week 18/day 126 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the safety of Cenobamate tablets vis-Ã -vis active control medication, i.e. Eslicarbazepine acetate by comparing treatment-emergent adverse events or serious adverse events Responder rate (response defined as a â?¥50% reduction in seizure frequency) â?? Analysis of subjects who experience a 50% or greater reduction in seizure frequency in the double-blind treatment period â?? comparison between treatment groups. Seizure freedom rate (all seizure types) during the 14-week treatment period. Time to the first Type I seizure during the treatment period Time to the fifth Type I seizure during the treatment period Time to the tenth Type I seizure during the treatment period Assessment of seizure frequency by seizure type: focal aware with motor component, focal impaired awareness, or focal to bilateral tonic-clonic â?? comparison between treatment groups.Timepoint: Visit 1: Baseline Visit at Day 00 Visit 2: Screening Visit: any time 2 weeks after baseline visit Visit 3: Enrollment Visit: week 4/day 28 Visit 4: Follow up Visit: week 5/day 35 Visit 5: Follow up visit: week 6/day 42 Visit 6: Follow up visit: Week 8/day 56 Visit 7: Follow up visit: Week 10/day 70 Visit 8: Follow up visit: Week 12/day 84 Visit 9: Follow up visit: week 15/day 105 Visit 10: Follow up visit: week 18/day 126 | — |
Countries
India
Contacts
Public ContactDr Mukund Zarapkar
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Outcome results
None listed