Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
Conditions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Seth GS Medical College and KEM Hospital Parel