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

Not Applicable

• Conditions: Health Condition 1: G40- Epilepsy and recurrent seizures

• Registration Number: CTRI/2019/06/019642
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in metabolic status in persons with epilepsy after 6 months of antiepileptic drug therapyTimepoint: At baseline/enrollment <br/ ><br>After 6 months of 6 months of antiepileptic drug therapy

Secondary Outcome Measures

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