Health Condition 1: A171- Meningeal tuberculoma
Conditions
Interventions
Intervention1: Tablet Thalidomide: The patients will be given oral Thalidomide as per 2-4 mg/kg body weight (assuming a standard adult weight between 50-60 kg: 100 mg to 240 mg) and the target dose wi
Sponsors
Indian Academy of Neurology
Eligibility
Inclusion criteria
Inclusion criteria: All patients with suspected CNS Tuberculoma diagnosed clinically and radiologically who have completed their intensive phase (two months) of ATT. CNS Tuberculoma causing any of the following: a. Raised Intracranial pressure with or without radiological and/or clinical herniation syndromes. b. Focal neurological deficit (loss of vision, hemiparesis, paraparesis, disabling persistent movement disorder or sensory loss) c. Drug refractory seizures/ status epilepticus Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure.
Exclusion criteria
Exclusion criteria: Any of the following: -Patients having associated cryptococcal meningitis. -Patients who are HIV positive. -Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy and lactation. -Patients who are diagnosed as multi drug resistant tuberculosis (MDR-TB) and are given second line ATT for longer duration. -Patients having multiple myeloma or any other form of cancer and are already receiving Thalidomide treatment. -Concurrent participation in any other therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom resolution at 3 months after randomizationTimepoint: symptom resolution at 3 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom resolution at 6 months. Radiological resolution at 3 and 6 months.Timepoint: 3 months. 6 months | — |
Countries
India
Contacts
Public ContactDeepti Vibha
All India Institute of Medical Sciences
Outcome results
None listed