Comparision between Newer and Older Antiepileptic drugs as monotherapy in Paediatric patients-A Observational study.
- 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
- 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.
- 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
Name Time Method 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
Name Time Method 1)Cognitive, emotional, social and physical functions 1 year
Trial Locations
- Locations (1)
Kalinga Institute Of Medical Sciences
🇮🇳Khordha, ORISSA, India
Kalinga Institute Of Medical Sciences🇮🇳Khordha, ORISSA, IndiaDr Abhisek RoutPrincipal investigator9776987173abhisek.rout90@gmail.com
