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

Evaluation of genotyping and therapeutic drug monitoring vs. only therapeutic drug monitoring as a strategy for risk minimization in epileptic patients on phenytoin therapy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021317
Enrollment
50
Registered
2019-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Sponsors

Dr Nithya Gogtay
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Nithya Gogtay

Seth GS Medical College and KEM Hospital Parel

njgogtay@hotmail.com9820495836

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026