Role of levetiracetam in Brain Tuberculosis
Phase 3
- Conditions
- Health Condition 1: A17- Tuberculosis of nervous system
- Registration Number
- CTRI/2024/06/069661
- Lead Sponsor
- GB Pant Institute of Post Graduate Medical Education and Research, New Delhi 110002
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of first epileptic seizure or till 3 months follow-up periodTimepoint: At baseline, 4 weeks, 8 weeks and 12 weeks
- Secondary Outcome Measures
Name Time Method A. Seizure related- Seizure severity of first seizure occurrence (Focal or generalized) <br/ ><br>B. Functional outcome-related <br/ ><br>B.1) Change in mRS compared with baseline <br/ ><br>B.2) Handicap score (Barthel index) compared with baseline <br/ ><br>C. The occurrence of side effects of the trial medication: using SIDAED scoreTimepoint: 90 days