Genotyping and Therapeutic Drug Monitoring in Epileptic patients on Phenytoin : RCT

Not Applicable

Completed

• Conditions: Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes

• Registration Number: CTRI/2019/09/021317
• Lead Sponsor: Dr Nithya Gogtay

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-05-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

i) Patients diagnosed with epilepsy ii) Patients on phenytoin therapy for at least 3 months duration

iii) Patients complaining of any ADRs to phenytoin like giddiness, headache, etc.

Exclusion Criteria

i) Patients with epilepsy on phenytoin therapy and are not willing to participate in the study

ii) Genotype (CYP2C9 and CYP2C19 polymorphism) results known to participant from prior testing or available in medical record

iii) Patients with neurological deficits

iv) Patients with history of drug /alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For risk minimization, we will look for safety outcome measures i.e. the difference in occurrence of ADRs in the 2 groupsâ?? a) patients those in which genotyping and TDM both will be done and b) those in which only TDM will be done during the follow up visits.Timepoint: Comparison of adverse event profile of the two groups will be done. Patients in both the groups will be followed up for one year (1, 3, 6 and 12 months).

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI