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

NCT02705768 | Completed Phase 4

• 1 other identifier: T/IM -NF/Pharm/15/30
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seizures, Focal

Keywords

Neuron-specific enolase (NSE); Carbamazepine; Oxcarbazepine

Outcome Measures

Primary Outcomes (1)

• Serum neuron-specific enolase (NSE) and S100B

  Method: ELISA

  Change from baseline over 4 weeks

Secondary Outcomes (2)

• Severity of seizure episode as measured by Chalfont-National Hospital seizure severity scale (NHS3)

  Change from baseline over 4 weeks

• Quality of life as assessed by Quality of Life in Epilepsy Inventory (QOLIE-31)

  Change from baseline over 4 weeks

Study Arms (3)

Healthy control

NO INTERVENTION

Twenty five (25) healthy individuals of same age group will serve as the control group. Control subjects will be evaluated at baseline only.

Carbamazepine group

EXPERIMENTAL

Twenty five (25) patients recruited in this group will receive Tab. 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: Carbamazepine

Oxcarbazepine group

EXPERIMENTAL

Twenty five (25) patients recruited in this group will receive Tab. 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.

Drug: Oxcarbazepine

Interventions

Carbamazepine DRUG

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.

Also known as: Tegretol

Carbamazepine group

Oxcarbazepine DRUG

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.

Also known as: Oxetol

Oxcarbazepine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients with the clinical diagnosis of localization related epilepsy/focal seizure (International League Against Epilepsy 2010) with a history of an episode of seizure within 48 hours of presentation

You may not qualify if:

• History of any recent traumatic brain injury, cerebral ischemia/transient ischemic attack/stroke
• Patients with neuroendocrinal tumours
• History of any invasive neurosurgical /non-invasive neuropsychiatric procedure.
• Patients who are already under treatment for the presenting conditions.
• Medication history of psychoactive or central nervous system depressant drugs
• Pregnant and nursing women

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (15)

• Sutula TP. Mechanisms of epilepsy progression: current theories and perspectives from neuroplasticity in adulthood and development. Epilepsy Res. 2004 Jul-Aug;60(2-3):161-71. doi: 10.1016/j.eplepsyres.2004.07.001.

  PMID: 15380560 RESULT

• Holmes GL. Seizure-induced neuronal injury: animal data. Neurology. 2002 Nov 12;59(9 Suppl 5):S3-6. doi: 10.1212/wnl.59.9_suppl_5.s3.

  PMID: 12428025 RESULT

• Henshall DC, Clark RS, Adelson PD, Chen M, Watkins SC, Simon RP. Alterations in bcl-2 and caspase gene family protein expression in human temporal lobe epilepsy. Neurology. 2000 Jul 25;55(2):250-7. doi: 10.1212/wnl.55.2.250.

  PMID: 10908900 RESULT

• Kato K, Ishiguro Y, Suzuki F, Ito A, Semba R. Distribution of nervous system-specific forms of enolase in peripheral tissues. Brain Res. 1982 Apr 15;237(2):441-8. doi: 10.1016/0006-8993(82)90455-3.

  PMID: 7044473 RESULT

• Royds JA, Davies-Jones GA, Lewtas NA, Timperley WR, Taylor CB. Enolase isoenzymes in the cerebrospinal fluid of patients with diseases of the nervous system. J Neurol Neurosurg Psychiatry. 1983 Nov;46(11):1031-6. doi: 10.1136/jnnp.46.11.1031.

  PMID: 6317805 RESULT

• DeGiorgio CM, Correale JD, Gott PS, Ginsburg DL, Bracht KA, Smith T, Boutros R, Loskota WJ, Rabinowicz AL. Serum neuron-specific enolase in human status epilepticus. Neurology. 1995 Jun;45(6):1134-7. doi: 10.1212/wnl.45.6.1134.

  PMID: 7783877 RESULT

• Correale J, Rabinowicz AL, Heck CN, Smith TD, Loskota WJ, DeGiorgio CM. Status epilepticus increases CSF levels of neuron-specific enolase and alters the blood-brain barrier. Neurology. 1998 May;50(5):1388-91. doi: 10.1212/wnl.50.5.1388.

  PMID: 9595992 RESULT

• Palmio J, Keranen T, Alapirtti T, Hulkkonen J, Makinen R, Holm P, Suhonen J, Peltola J. Elevated serum neuron-specific enolase in patients with temporal lobe epilepsy: a video-EEG study. Epilepsy Res. 2008 Oct;81(2-3):155-60. doi: 10.1016/j.eplepsyres.2008.05.006. Epub 2008 Jul 1.

  PMID: 18595663 RESULT

• Chang CC, Lui CC, Lee CC, Chen SD, Chang WN, Lu CH, Chen NC, Chang AY, Chan SH, Chuang YC. Clinical significance of serological biomarkers and neuropsychological performances in patients with temporal lobe epilepsy. BMC Neurol. 2012 Mar 14;12:15. doi: 10.1186/1471-2377-12-15.

  PMID: 22417223 RESULT

• Buttner T, Lack B, Jager M, Wunsche W, Kuhn W, Muller T, Przuntek H, Postert T. Serum levels of neuron-specific enolase and s-100 protein after single tonic-clonic seizures. J Neurol. 1999 Jun;246(6):459-61. doi: 10.1007/s004150050383.

  PMID: 10431771 RESULT

• Rabinowicz AL, Correale J, Boutros RB, Couldwell WT, Henderson CW, DeGiorgio CM. Neuron-specific enolase is increased after single seizures during inpatient video/EEG monitoring. Epilepsia. 1996 Feb;37(2):122-5. doi: 10.1111/j.1528-1157.1996.tb00002.x.

  PMID: 8635421 RESULT

• Duncan JS, Sander JW. The Chalfont Seizure Severity Scale. J Neurol Neurosurg Psychiatry. 1991 Oct;54(10):873-6. doi: 10.1136/jnnp.54.10.873.

  PMID: 1744641 RESULT

• Cramer JA, French J. Quantitative assessment of seizure severity for clinical trials: a review of approaches to seizure components. Epilepsia. 2001 Jan;42(1):119-29. doi: 10.1046/j.1528-1157.2001.19400.x.

  PMID: 11207795 RESULT

• Cramer JA, Perrine K, Devinsky O, Bryant-Comstock L, Meador K, Hermann B. Development and cross-cultural translations of a 31-item quality of life in epilepsy inventory. Epilepsia. 1998 Jan;39(1):81-8. doi: 10.1111/j.1528-1157.1998.tb01278.x.

  PMID: 9578017 RESULT

• Maiti R, Mishra BR, Sanyal S, Mohapatra D, Parida S, Mishra A. Effect of carbamazepine and oxcarbazepine on serum neuron-specific enolase in focal seizures: A randomized controlled trial. Epilepsy Res. 2017 Dec;138:5-10. doi: 10.1016/j.eplepsyres.2017.10.003. Epub 2017 Oct 6.

  PMID: 29028517 DERIVED

MeSH Terms

Conditions

Seizures

Interventions

Carbamazepine; Oxcarbazepine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• DEBASISH HOTA, DM

  AIIMS, Bhubaneswar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)