Health Condition 1: null- REFRACTORY PARTIAL-ONSET SEIZURES
Conditions
Interventions
Intervention1: IN-AQUL-002: Start study medication as one tablet once daily. At first follow-up if medication is well tolerated then escalate the dose to two tablets once daily. In case need for furth
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the seizure frequency rateTimepoint: At the endpoint compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Responder Rate 2. Change in number of seizure free days Timepoint: At the endpoint compared to baseline | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
Medical Advisor
Outcome results
None listed