Genotyping and TDM in Epileptic patients on CBZ : RCT
Not Applicable
Completed
- Conditions
- Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
- Registration Number
- CTRI/2019/09/021311
- Lead Sponsor
- Dr Nithya Gogtay
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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
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.
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: Baseline, 1, 3, 6 & 12 months
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI