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Clinical Study to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures

Phase 3
Conditions
Partial-onset seizures
Registration Number
CTRI/2010/091/001194
Lead Sponsor
Emcure Pharmaceuticals Ltd., Pune
Brief Summary

This is a openlabel, randomized, multi-center, phase III clinical trial conducted to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures. A total of 200 patients will be enrolled in the study. All patients will receive either Eslicarbazepine acetate 400 mg tablet or Oxcarbazepine 300 mg tablet. For both the treatment groups, the starting dose will be lower strength. In subsequent visits dose may be titrated, if clinically required. All patients will be evaluated every two weeks for efficacy and safety variables during 3 months of therapy. The primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency. The secondary efficacy variables will 1) Seizure frequency per 4 weeks; 2) Number of days with seizure; 3) Proportion of seizure free subjects 4) Proportion of patients with an exacerbation in seizure frequency (≥ 25%); 5) Distribution of seizure reduction (proportion of patients with seizure reduction of 50%; ≥ 50 ? 75% or > 75%); 6) Subjects? global assessment for efficacy; 7) Physicians? global assessment for efficacy. The safety variables will be Clinical: 1) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator; 2) Subject?s global assessment about the tolerability of the drug; 3) Physician?s global assessment about the tolerability of the drug Investigational: Subjects will be evaluated for CBC (Complete Blood Count), LFT (Liver Function Test), KFT (Kidney Function Test) Lipid profile, FBG (Fasting Blood Glucose), and ECG (Electrocardiogram)

Detailed Description

Not available

Recruitment & Eligibility

Sex
Not specified
Target Recruitment
200
Inclusion Criteria
  • 1.Male and Female subjects between 18 to 65 years of age.2.Subjects diagnosed with simple or complex partial seizures with or without secondary generalization and taking stable doses of antiepileptic drugs for at least 2 weeks.
  • 3.Subjects with at least 2 partial ?
  • onset seizures per month OR 4 partial ?
  • onset seizure in last 2 months in spite of treatment with following one to two (1-2) antiepileptic drugs: phenytoin, valproic acid, primidone, phenoparbital, lamotrigine, gabapentin, topiramate, clonazepam, carbamazepine and levetiracetam OR any other antiepileptic drugs except Eslicarbazepine/ oxcarbazepine.4.Subject willing to give written informed consent and willing to comply with trial protocol.
Exclusion Criteria
  • 1.Subjects with primary generalized seizure.2.Subjects with known progressive neurological disorder.3.Subjects with episode of status epilepticus or cluster seizure within past 3 months.
  • 4.Subjects with seizure of non-epileptic origin.5.Subjects with major psychiatric illness or previous suicidal attempts.
  • 7.Known hypersensitivity to eslicarbazepine, carbamazepine, oxcarbazepine, tricyclic compounds OR known hypersensitivity to any constituent of the Test/ Reference formulation.
  • 8.Subjects with cardiac arrhythmia or any abnormality on ECG.9.Subjects with previous history of bone marrow depression.10.Patients with significant hematological / metabolic / endocrinologial (excluding type 2 Diabetes Mellitus) / respiratory/cardiac/liver/kidney/psychiatric diseases 11.Pregnant and lactating mother.12.Female of reproductive age and willing to become pregnant.13.Female of reproductive age using steroidal/hormonal contraceptives.
  • 14.Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug.15.Patients with Alcohol or drug abuse.16.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Study & Design

Study Type
Not specified
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks
Secondary Outcome Measures
NameTimeMethod
1.Seizure frequency per 4 weeks2.Number of days with seizure3.Proportion of seizure free subjects4.Proportion of subjects with an exacerbation in seizure frequency (≥ 25%)5.Distribution of seizure reduction (proportion of subjects with seizure reduction of 50%; ≥ 50 ? 75% or > 75%)6.Subjects? global assessment for efficacy 7.Physicians? global assessment for efficacy0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks

Trial Locations

Locations (4)

Neuro care hospital,

🇮🇳

Nashik, MAHARASHTRA, India

Nirvaan Neuro Centre

🇮🇳

Kannur, KERALA, India

Noble Hospital

🇮🇳

Pune, MAHARASHTRA, India

Sahyadri Hospital,

🇮🇳

Nashik, MAHARASHTRA, India

Neuro care hospital,
🇮🇳Nashik, MAHARASHTRA, India
Dr Rahul Baviskar
Principal investigator
rbaviskar@gmail.com

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