Methodology

This randomized double blind placebo controlled study will consist of patient of CNS tuberculosis. There will be two groups one interventional group and other comparator group who will be given trial medication 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/kg/day in two divided doses (upper limit 4gm/day). This will continue for the entire study period and after 12 weeks, the trial medication will be tapered off by 250 mg each 3 days and eventually discontinued. If patient reports intolerable side effects in which case the drug dose will be decreased to the

tolerable level, but not below 20 mg/kg/day. If patient does not tolerate the lowest permissible dose, it will be stopped and the side effects will be managed free of cost as per standard of care. If patient has a seizure in the follow-up period, another anti-seizure medication (ASM) other than levetiracetam will be added as per acute symptomatic seizure management guidelines. Patient will be followed up after 7 days, 30 days and 60 days to enquire about history of any possible epileptic seizures & any drug-related side effects which will be assessed by SIDEADquestionnaire. The follow-up will be done on a OPD basis or telephonically if OPD follow up not possible. Final follow-up will be done at 90 days. Parameters like patient mRS, seizure occurrence, adverse effects of ASM (SIDEAD), BI will be recorded by direct face-to-face patient interaction.