Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
Conditions
Sponsors
Dr Nithya Gogtay
Eligibility
Inclusion criteria
Inclusion criteria: i) Patients diagnosed with epilepsy. ii) Patients on CBZ therapy for at least 3 months iii) Patients complaining of any ADRs to CBZ like giddiness, dizziness, etc. or no ADRs like giddiness, dizziness, etc.
Exclusion criteria
Exclusion criteria: i) Patients with epilepsy on CBZ therapy and are not willing to participate in the study. ii) Genotype (CYP3A5 polymorphism) results known to participant from prior testing or available in medical record iii) Patients with neurological deficits (physical deficits e.g. paraparesis or paraplegia) iv) Patients with history of drug /alcohol abuse v) Evidence of gastrointestinal tract, renal, endocrine, cardiovascular diseases, etc.
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: Baseline, 1, 3, 6 & 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Nithya Gogtay
Seth GS Medical College and KEM Hospital, Parel
Outcome results
None listed