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Seizure recurrence chance after antiepileptic drug withdrawal and its correlation with drug level and other laboratory parameters

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/04/008392
Enrollment
330
Registered
2017-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Persons with epilepsy undergoing antiepileptic drug tapering after more than 2 years of seizure free period

Interventions

None listed

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Rate of seizure recurrence in PWE on monotherapy undergoing AED tapering with minimum 1 year follow up periodTimepoint: 1 year follow up period

Secondary

MeasureTime frame
ï?? Correlation between the lowering of serum AED concentration with seizure recurrence in PWE on monotherapy undergoing AED taperingTimepoint: 1 year follow up period;ï?? Correlation of the following factors with seizure recurrence with treatment, seizure, inflammatory biomarkers- TNF alpha, IL-1 betaTimepoint: 1 year follow up period

Countries

India

Contacts

Public ContactProfessor Manjari Tripathi

All India Institute of Medical Sciences, New Delhi

scsarangi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026