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

Phase 3

Completed

• Registration Number: CTRI/2010/091/001194
• Lead Sponsor: Emcure Pharmaceuticals Ltd., Pune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• 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.
6.Patients taking concurrent drug therapies with: Monoamine oxidase inhibitor (MAO), Calcium channel blockers (CCB), falbamate, diuretics, desmopressin, warfarrin, nefazodone and oxcarbazepine.
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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequencyTimepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Seizure frequency per 4 weeks<br>2.Number of days with seizure<br>3.Proportion of seizure free subjects<br>4.Proportion of subjects with an exacerbation in seizure frequency (&amp;#8805; 25%)<br>5.Distribution of seizure reduction (proportion of subjects with seizure reduction of 50%; &amp;#8805; 50 ? 75% or &gt; 75%)<br>6.Subjects? global assessment for efficacy <br>7.Physicians? global assessment for efficacy<br>Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks