13-WEEK STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 TABLET COMPARED TO OXCARBAZEPINE SUSTAINED-RELEASE TABLET AS ADJUNCTIVE TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURES

Phase 3

• Conditions: Health Condition 1: null- REFRACTORY PARTIAL-ONSET SEIZURES

• Registration Number: CTRI/2010/091/006085
• Lead Sponsor: Intas Pharmaceuticals Limited

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: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 270

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 &#8805; 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 &#8805; 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the seizure frequency rateTimepoint: At the endpoint compared to baseline <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Responder Rate <br/ ><br>2.Change in number of seizure free days <br/ ><br>Timepoint: At the endpoint compared to baseline <br/ ><br> <br/ ><br>