NCT02705768

Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: All India Institute of Medical Sciences, Bhubaneswar · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The present study has been planned to assess the level of serum neuron-specific enolase (NSE) in focal seizures and its changes after antiepileptic therapy.

Detailed description

Epileptic seizures can cause neuronal cell death, enhanced neurogenesis, axonal sprouting, dendritic changes, and reactive gliosis. Histopathological analyses have suggested that the initial insult and recurrent seizures contribute to the neuronal damage. Activation of mesial temporal structures is more likely to cause damage than that of other areas of brain; therefore, one of the consequences of prolonged seizures is selective neuronal loss in the hippocampus. The excitotoxic damage is considered the most important mechanism of injury but there is also evidence that programmed cell death contributes to neuronal damage. Various biomarkers of brain damage have been studied in the context of epilepsy and brain damage but most widely investigated biochemical biomarker is neuron-specific enolase (NSE). NSE is γγ-isoenzyme of enolase involved in glycolysis pathway. NSE originates predominantly from the cytoplasm of neurons and neuroendocrine cells. Neuronal damage and impairment of blood brain barrier integrity can be detected by the release of NSE into cerebrospinal fluid (CSF) and eventually into blood. NSE is therefore regarded as a marker of neuronal damage and prognosis in various disorders associated with cell damage in the central or peripheral nervous system. CSF and serum NSE levels obtained within first 48 hours were found to be elevated and correlated well with the duration of epilepsy and outcome of patients. Some studies have shown elevated NSE levels in temporal lobe epilepsy, after single tonic-clonic seizures, and status epilepticus. Literature review reveals that there is lack of data on serum NSE in focal seizures and there is no study on the effect of antiepileptic drugs on the level of serum NSE. So the present study has been planned to assess the level of serum NSE in focal seizures and its changes after antiepileptic therapy.

Conditions

• Seizures, Focal

Interventions

Type	Name	Description
DRUG	Carbamazepine	Carbamazepine will be started with a dose of 200 mg/day for one week and then increased to 400 mg/day for one week and then 600mg/day for next two weeks.
DRUG	Oxcarbazepine	Oxcarbazepine will be started with 10mg/kg daily dose for one week followed by 15mg/kg daily for next one week and then will be increased to 20mg/kg for next two weeks.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2016-03-11
• Last updated: 2017-09-19

Locations

1 site across 1 country: India