A clinical trial to study the effects of of levetiracetam as a first line monotherapy in patients (>16 years) with partial seizures with or without secondary generalization

An open, multicentric non-comparative study to evaluate, the efficacy and safety of levetiracetam as a first line monotherapy in patients(>16years of age) with partial seizures with or without secondary generalization

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000265

Enrollment

Registered

2011-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Levetiracetam 500mg: Treatment will be initiated with a daily dose of 500mg/day, given as twice daily dosing (250 mg BID), with or without food. After two weeks dose will be increased

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex with established diagnosis of partial seizures with or without secondary generalization. 2.Age above 16 years. 3.Newly diagnosed or treatment naïve epilepsy patients 4.Willing to give informed consent (for age above 16 years) 5.Women willing to use adequate contraceptive methods

Exclusion criteria

Exclusion criteria: 1.Patients with seizures other than partial seizures with or without secondary generalization. 2.Patients with any progressive brain disease. 3.Patients with history of pre existing behavioral impairment 4.Patients with hepatic or renal impairment 5.Patients with severe obstructive respiratory disease 6.Patients with a clinically significant disorder which needs treatment. 7.Patients with acute intermittent porphyria 8.Patients currently on other antiepileptics 9.Patients on oral anticoagulants 10.Patients receiving corticosteroids 11.Patients receiving griseofulvin 12.Women who are pregnant or conceive during the study period

Design outcomes

Primary

Measure	Time frame
a.Six months seizure freedom b.Twelve months seizure freedom Timepoint: Screening, Baseline , Day 30, Day 180 and Day 360	—

Secondary

Measure	Time frame
a.Seizure free interval b.Safety c.Retention rate Timepoint: Screening, Baseline , Day 30, Day 180 and Day 360	—

Countries

India

Contacts

Public ContactManoj.M.Prabhu

Chief Manager

manoj.naik@piramal.com022-39536910

Outcome results