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effect of antiepileptic drug levetiracetam and valproate on the chemical processes for sustaining life in persons with epilepsy

EFFECT OF ANTIEPILEPTIC DRUG MONOTHERAPY WITH LEVETIRACETAM AND VALPROATE ON METABOLIC STATUS IN PERSONS WITH EPILEPSY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/06/019642
Enrollment
100
Registered
2019-06-12
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: G40- Epilepsy and recurrent seizures

Interventions

None listed

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed persons with epilepsy (PWE) Subject 18 to 50 years old either male and female Subjects going to start or already on AED (valproate and levetiracetam) monotherapy for not more than 3 months Patient ready to give informed consent

Exclusion criteria

Exclusion criteria: Pregnant or lactating women Associated neurological diseases other than epilepsy Any other active disease (e.g. infectious, psychiatric, disabling chronic diseases) likely to impair metabolic status and physical activity Walking abnormalities including leg injuries, bone fractures, congenital abnormalities Patient on anti-tubercular drugs or any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.) Patient with significant hepatic and renal impairment that may require dose alteration. Patient refuses to give informed consent

Design outcomes

Primary

MeasureTime frame
changes in metabolic status in persons with epilepsy after 6 months of antiepileptic drug therapyTimepoint: At baseline/enrollment After 6 months of 6 months of antiepileptic drug therapy

Secondary

MeasureTime frame
correlate above changes in metabolic status with serum antiepileptic drug level and physical activity scoreTimepoint: Baseline and 6 months after follow up

Countries

India

Contacts

Public ContactSudhir Chandra Sarangi

AIIMS, New Delhi

scsarangi@gmail.com

Outcome results

None listed

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