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CTRI Number  CTRI/2025/06/088953 [Registered on: 16/06/2025] Trial Registered Prospectively
Last Modified On: 15/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of tablet Thalidomide in the treatment of Tuberculous mass lesion (tuberculoma) in the brain 
Scientific Title of Study   Thalidomide in the treatment of tuberculoma: A prospective randomized open blinded endpoint (PROBE) study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepti Vibha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 707, Neurosciences Center Department of Neurology

South
DELHI
110029
India 
Phone  9868398263  
Fax  01126594485  
Email  deeptivibha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepti Vibha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 707, Neurosciences Center Department of Neurology

South
DELHI
110029
India 
Phone  9868398263  
Fax  01126594485  
Email  deeptivibha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepti Vibha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 707, Neurosciences Center Department of Neurology

South
DELHI
110029
India 
Phone  9868398263  
Fax  01126594485  
Email  deeptivibha@gmail.com  
 
Source of Monetary or Material Support  
Indian Academy of Neurology, India 
 
Primary Sponsor  
Name  Indian Academy of Neurology 
Address  Dr. U.Meenakshisundaram Secretary, Indian Academy of Neurology 
Type of Sponsor  Other [National society for Neurologists in India] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepti Vibha  All India Institute of Medical Sciences  Room number 707, Department of Neurology, All India Institute of Medical Sciences, New Delhi
South
DELHI 
011-26594485

deeptivibha@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A171||Meningeal tuberculoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard medical treatment   This will include ATT and steroid as deemed suitable by the treating team.  
Intervention  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 will be based on the tolerability of the patient. The treatment will be given for a period of two months. This treatment will be in addition to the standard medical treatment 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
symptom resolution at 3 months after randomization  symptom resolution at 3 months after randomization 
 
Secondary Outcome  
Outcome  TimePoints 
Symptom resolution at 6 months.
Radiological resolution at 3 and 6 months.  
3 months. 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

No randomized controlled trials (RCTs) have been conducted till date to determine the efficacy of Thalidomide in treating CNS tuberculoma. This is despite it being a clinical challenge in endemic areas. Most of these patients are on prolonged ATT, second line ATT as well as recurrent or persistent high doses of corticosteroids, with resultant side effects of the same. So, there is significant knowledge gap in treatment of CNS tuberculomas.  The evidence of efficacy of Thalidomide is limited to case reports and cohorts of paediatric patients, although it equally affects adult patients as well.

Our study would be the first of its kind to explore an adjuvant therapy for better resolution of CNS tubercular lesions along with standard treatment. Our clinical trial would also help in determining the safety and efficacy of thalidomide in treating CNS tuberculoma patients. This novel treatment would also help in determining the significance of Thalidomide in resolving paradoxical lesions developing during ATT regimen. Recovery from CNS Tuberculoma is long and critical process and using an adjuvant like Thalidomide to reduce the recovery time would also make the entire process of treating CNS TB cost-effective, especially in resource-limited settings.

Therefore, our hypothesis is that Thalidomide used as an adjuvant along with ATT and corticosteroids for treatment of CNS tuberculoma would be safe and effective in resolution of CNS tuberculoma in terms of functional outcome and radiological improvement.

 
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