AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 IN COMPARISON WITH OXCARBAZEPINE SUSTAINED-RELEASE AS ADJUNCTIVE TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURES

Intas Pharmaceuticals Limited0 个研究点目标入组 270 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients of either sex, 18 to 65 years of age (both inclusive), undergoing treatment with one to three anti-epileptic drugs (AEDs) for simple or complex partial seizures with or without secondary generalization & having history of at least two partial-onset seizures in the previous 4 weeks before screening
•2.In case of females with childbearing potential, non-pregnant, non-lactating, with negative serum pregnancy test at screening and willing to use barrier contraceptive throughout the study treatment period
•3.Patients willing to provide written informed consent
•4.Patients willing to comply with the study requirements such as regular recording of seizure diary and self administration of study medication throughout the study treatment period

•Patients with
•1.Only simple partial seizures without motor symptoms,
•2.Primarily generalized epilepsy
•3.Known rapid progressive neurological disorder,
•4.Status epilepticus/cluster seizures within 3 months before screening
•5.Seizures of psychogenic origin within the last two years
•6.History of schizophrenia or suicide attempts
•7.An uncontrolled, relevant medical disorder
•8.Ongoing use of disallowed medications including oxcarbamazepine, feblamate, diuretics (conventional diuretic doses), desmopressin,
•9.Cardiac arrhythmia including atrioventricular blockade
•10.Clinical laboratory abnormalities (SGPT/OT ≥ 2.5 times upper normal limit; or sodium < 130 mmol/L or total white blood cell count < 3,000 cells/mm3; hematocrit < 35%; free T4 < 77 ng/100ml & T3 < 2.4 pg/ml; or serum creatinine ≥ 1.5mg/100ml).
•11.History of drug or alcohol abuse within the previous 2 years
•12.Known hypersensitivity to carbamazepine or oxcarbazepine formulations
•13.Participation in other investigational drug trial within 3 months preceding study entry
•14.As deemed inappropriate for enrollment by investigating physician due to other reasons.

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