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Comparision between Newer and Older Antiepileptic drugs as monotherapy in Paediatric patients-A Observational study.

Not yet recruiting
Conditions
Mental disorder, not otherwise specified,
Registration Number
CTRI/2020/12/029516
Lead Sponsor
Dr Abhisek Rout
Brief Summary

Epilepsy is a common chronic neurologic disorder that requires long term medication in children. In recent years many Anti Epileptic Drugs (AEDs) have been discovered. Adverse Drug Reactions (ADRs) are quite common due to AEDs and are common causes of treatment failure. Lack of seizure control and intolerable ADRs affect cognitive, emotional, social and physical functioning of children. There is lack of data on the efficacy and safety of newer AEDs.With the increase in use of New AEDs there is greater need to determine  the effectiveness of these drugs in paediatric population. This study will aim to:

Ø- -To compare the efficacy of Newer (Levetiracetam, Topiramate, Oxcarbazepine etc) as well as Older (Phenytoin, Valproic Acid, Phenobarbitone etc ) AEDs as monotherapy in paediatric population.

Ø  - To compare ADRs due to older and newer AEDs.

Ø   -  To assess the Quality Of Life (QOL) in paediatric population on AEDs.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
324
Inclusion Criteria
  • 1)Epileptic patients aged between 2 – 12 years.
  • 2)Patients prescribed monotherapy of AEDs. 3)Newly diagnosed patients of epilepsy.
  • 4)Previously diagnosed and treatment failure patients.
  • 5)Previously diagnosed and treated patients presenting with ADRs. 6)Patients having seizures due to drugs, any trauma or diseases.
  • 7)Less than one seizure per year prior to treatment.
Exclusion Criteria
  • 1)Patients diagnosed with cryptogenic epilepsy.
  • 2)Patients who are treated with more than one AED.
  • 3)Drug resistant patients.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1)Proportion of patients achieving seizure free days during period of study.1 year
2)Incidence, Prevalence and severity/seriousness of ADRs.1 year
Secondary Outcome Measures
NameTimeMethod
1)Cognitive, emotional, social and physical functions1 year

Trial Locations

Locations (1)

Kalinga Institute Of Medical Sciences

🇮🇳

Khordha, ORISSA, India

Kalinga Institute Of Medical Sciences
🇮🇳Khordha, ORISSA, India
Dr Abhisek Rout
Principal investigator
9776987173
abhisek.rout90@gmail.com

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