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CTRI Number  CTRI/2023/05/052417 [Registered on: 09/05/2023] Trial Registered Prospectively
Last Modified On: 18/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of thalidomide in complicated tubercular infection of brain 
Scientific Title of Study   Study of efficacy of thalidomide in complicated tubercular infection of central nervous system 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish Modi 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of Neurology PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  modipgi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manish Modi 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of Neurology PGIMER, Chandigarh


CHANDIGARH
160012
India 
Phone    
Fax    
Email  modipgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Siddharth Chand 
Designation  Senior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department of Neurology PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  siddharthchand@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  PGIMER Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Siddharth Chand  PGIMER Chandigarh  Department of Neurology, Ground Floor, A block, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH 		 9013346436

siddharthchand@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural))   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capsule Thalidomide   Patients allocated to intervention group will receive capsule thalidomide 50mg twice daily (patient’s weight 50kg) or thrice daily (weight ≥ 50kg) for 3 to 6 months along with standard regimen of ATT with steroids. 
Comparator Agent  Tablet prednisolone   Patients allocated to comparison group will tablet prednisolone 20mg twice daily (patient’s weight 50kg) or thrice daily (weight ≥ 50kg) along with standard regimen of ATT for 3-6 months. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Possible, probable, or definite TBM as diagnosed by Marais et al criteria.
Patients already on standard ATT and steroid protocol for CNS TB who develop complications in the form of paradoxical worsening like opto-chiasmatic syndrome, spinal arachnoiditis, increase in tuberculomas, exudates or clinical worsening etc.
Patients willing to be followed up for at least 6 months for assessment.
 
 
ExclusionCriteria 
Details  1. Patients who are either HIV positive or immunocompromised due to some other disease.
2. Patients are on immunosuppressive drugs.
3. Patients who cannot undergo lumbar puncture or MRI examination.
4. Pregnant patients.
5. CSF gram stain or/and culture showing microorganisms other than acid fast bacilli.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome – Mortality at 6 months of intervention.
Secondary outcome –
• Clinical improvement
o Functional status – mRS scale.
o Vision – Grading of Visual Acuity
• Radiological improvement
o Exudates – Present or absent.
o Tuberculomas – Number
o Infarct – Present or absent.
o Hydrocephalus – Present or absent.
• Presence of neurological deficit
• Side effects of thalidomide
 		 Primary outcome – Mortality at 6 months of intervention.
Secondary outcome –
• Clinical improvement
o Functional status – mRS scale.
o Vision – Grading of Visual Acuity
• Radiological improvement
o Exudates – Present or absent.
o Tuberculomas – Number
o Infarct – Present or absent.
o Hydrocephalus – Present or absent.
• Presence of neurological deficit
• Side effects of thalidomide
 
 
Secondary Outcome  
Outcome  TimePoints 
• Clinical improvement
o Functional status – mRS scale.
o Vision – Grading of Visual Acuity (Wall et al) (36)
Grading Visual Acuity
Mild vision loss 6/9 – 6/12
Moderate Vision loss 6/18 – 6/60
Severe Vision loss 6/60
• Radiological improvement
o Exudates – Present or absent.
o Tuberculomas – Number
o Infarct – Present or absent.
o Hydrocephalus – Present or absent.
• Presence of neurological deficit
• Side effects of thalidomide
 		 1,2,3,4,5,6 months  
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 2/ Phase 3 
Date of First Enrollment (India)   16/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Tuberculosis (TB) caused by Mycobacterium tuberculosis (M.tb) continues to be a major public health challenge. According to the Global tuberculosis report 2022 by WHO, an estimated 10.6 million fell ill with TB in 2021 with 1.6 million people succumbing to the disease (1). 5-15% of all cases of TB affect extrapulmonary sites; and 1% of all cases infect the central nervous system (CNS) (2,3). Whilst the overall percentage of infliction of the CNS is small, it causes much more morbidity and mortality. TB is known to affect the meninges of the brain leading to tubercular meningitis (TBM) and can also infect the spinal cord, and the parenchyma.
The optimal management of TBM remains unresolved. Much of the morbidity and mortality caused in a case of infection of nervous system is due to dysregulated immune response. Immunomodulation is thus maybe useful in the management of patients who suffer from immune mediated complications. 
Presently only corticosteroids are approved for the treatment of TBM along with anti-tubercular drugs. An analysis from nine trials have shown that steroids reduce mortality from tuberculous meningitis, at least in the short term (4). Corticosteroids may have no effect on the number of people who survive tuberculous meningitis with disabling neurological deficit, but this outcome is less common than death. However even with the concomitant use of corticosteroids the morbidity and mortality continue to be high. 
Accumulating evidence throws light on the role of various cytokines in the pathogenesis of exaggerated immune response to M.tb. Tumor necrosis factor alpha (TNF- α) is essential to control M.tb replication, however increased concentration leads to severe tissue damage (5). Thalidomide, which is approved for use in erythema nodosum leprosum decreases TNF- α production in a dose dependent manner (6). Observational studies have shown potential benefit of thalidomide in treatment of TBM with early clinical and radiological resolution of disease. 
Data from randomized controlled trial (RCT) regarding the efficacy of thalidomide in TBM and CNS TB is lacking. We aim to conduct a RCT  to study the efficacy of thalidomide in TBM.

 
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