Health Condition 1: A17- Tuberculosis of nervous system
Conditions
Interventions
Intervention1: Tablet Levetiracetam: Tablet Levetiracetam will be started in the dose of 20 mg/kg in two divided doses and gradually increased by 10 mg/kg every 3rd day to a maintenance dose of 40 mg/
Sponsors
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi 110002
Eligibility
Inclusion criteria
Inclusion criteria: Patients with CNS Tuberculosis will be included fulfilling following criteria: 1. Within 6 months of diagnosis 2. At high risk for seizures that will include one or more of the following: A. Grade II and III MRC stage B. Epileptiform discharges on EEG C. Abnormal neuroimaging (supra-tentorial tuberculoma or abscess or leptomeningeal enhancement or cortical infarct or hydrocephalus)
Exclusion criteria
Exclusion criteria: 1. Age less than or equal to 12 years 2. Diagnosed case of seizure disorder or taking anti-seizure medication 3. Advanced kidney or liver disease 4. Pregnancy or breastfeeding 5. Contraindication to the use of Levetiracetam (significant neuropsychiatric symptoms, depression, psychosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of first epileptic seizure or till 3 months follow-up periodTimepoint: At baseline, 4 weeks, 8 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| A. Seizure related- Seizure severity of first seizure occurrence (Focal or generalized) B. Functional outcome-related B.1) Change in mRS compared with baseline B.2) Handicap score (Barthel index) compared with baseline C. The occurrence of side effects of the trial medication: using SIDAED scoreTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Kanika Agarwal
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi
Outcome results
None listed