| 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
|
|
|
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
|
|
|
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. |