Measurement of blood levels of levetiracetam in patients with fits

Phase 4

Recruiting

• Conditions: Epilepsy

• Registration Number: CTRI/2017/12/010835
• Lead Sponsor: KEM Hospital

Brief Summary

Levetiracetam is a second line anti epileptic drug. In the last few years, its use has expanded considerably. However, very few centres estimate blood levels to individualize drug therapy in patients with epilepsy. Hence this study was planned to set up and validate a HPLC method for estimation of Levetiracetam and subsequently use Therapeutic Drug Monitoring to individualize treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

All patients on Levetiracetam for at least one year.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure control	At one month, six months and one year when they come for blood level estimation

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with good seizure control, levels in patients with renal dysfunction	Monthly for the first six months after study initiation and six monthly subsequently

Trial Locations

Locations (1)

KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

KEM Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Mamta Muranjan

Principal investigator

02224107645

muranjanmamta@rediffmail.com