CTRI/2010/091/001194
Completed
Phase 3
Clinical Study to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures
Emcure Pharmaceuticals Ltd., Pune0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd., Pune
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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