CTRI/2010/091/006085OtherPhase 3
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
Trial Snapshot
- Phase
- Phase 3
- Status
- Other
- Enrollment
- 270
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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