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Clinical Trials/CTRI/2017/04/008392
CTRI/2017/04/008392
Recruiting
未知

A prospective observational study to find out correlation of serum antiepileptic drug (AED) and biomarkers levels with seizure recurrence in persons with epilepsy (PWE) undergoing AED tapering

All India Institute of Medical Sciences New Delhi0 sites330 target enrollmentTBD
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ConditionsHealth Condition 1: null- Persons with epilepsy undergoing antiepileptic drug tapering after more than 2 years of seizure free period

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Persons with epilepsy undergoing antiepileptic drug tapering after more than 2 years of seizure free period
Sponsor
All India Institute of Medical Sciences New Delhi
Enrollment
330
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
All India Institute of Medical Sciences New Delhi

Eligibility Criteria

Inclusion Criteria

  • •1\. Clinically diagnosed persons with epilepsy (PWE)
  • •2\. Either male or female, age more than 18 years
  • •3\. On monotherapy of AEDs (valproic acid, carbamazepine, phenytoin and levetiracetam)
  • •4\. Two years seizure freedom or longer
  • •5\. PWE going to start AED tapering
  • •6\. Patient ready to give informed consent

Exclusion Criteria

  • •1\. Juvenile myoclonic epilepsy
  • •2\. Pregnant or seeking pregnancy
  • •3\. Associated neurological diseases other than epilepsy
  • •4\. Patient on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.)
  • •5\. Patient with significant hepatic and renal impairment that may require dose alteration
  • •6\. Patient on anti tubercular drugs or any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.)
  • •7\. Patient on food or dietary supplements like grape fruit juice and ginkgo biloba which are known to cause interaction with AEDs
  • •8\. Any associated psychiatric disorder
  • •9\. Any chronic inflammatory disorder (e.g. Autoimmune disorder like RA, IBD, bronchial asthma)
  • •10\. Patient refuses to give informed consent

Outcomes

Primary Outcomes

Not specified

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