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CTRI Number  CTRI/2024/01/061209 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of early vs late Plasma exchange in the treatment of acute weakness of limbs 
Scientific Title of Study   Comparison of simultaneous plasma exchange (PLEX) and Intravenous methylprednisolone (IVMPS) versus IVMPS with add on PLEX in the treatment of acute severe myelitis of Neuromyelitis optica spectrum disorders (NMOSD): A prospective randomized open label blinded endpoint (PROBE) study 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Kumar Singh 
Designation  Additional professor 
Affiliation  AIIMS 
Address  Room no.703 Cardio Neuro center Department of Neurology AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594049  
Fax    
Email  drrajeshrims679@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumar Singh 
Designation  Additional professor 
Affiliation  AIIMS 
Address  Room no.703 Department of Neurology Cardio Neuro center AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594049  
Fax    
Email  drrajeshrims679@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar Singh 
Designation  Additional professor 
Affiliation  AIIMS 
Address  Room no.703 Department of Neurology Cardio Neuro center AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594049  
Fax    
Email  drrajeshrims679@gmail.com  
 
Source of Monetary or Material Support  
Material support- All India Institute of Medical Sciences, New Delhi Funding Agency-Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911,Ansari Nagar, 110029 New Delhi, India  
 
Primary Sponsor  
Name  ICMR 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911,Ansari Nagar, 110029 New Delhi, India 
Type of Sponsor  Government funding agency 
 
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 Rajesh Kumar Singh  AIIMS  Department of Neurology, Room No- 703, CN Center New Delhi.
New Delhi
DELHI 		 01126594049

drrajeshrims679@gmail.com 
 
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: G373||Acute transverse myelitis in demyelinating disease of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Add on Therapy  IVMPS 1 gm/day will be given for 5 days. Add on PLEX 5 cycles alternate day (39-55 ml plasma/kg/session) will be given if there is inadequate or poor response to IVMPS. 
Intervention  Simultaneous Therapy  Simultaneous IVMPS and plasma exchange will be started.IVPMS 1 gm/day will be given for 5 days. 5 cycles of PLEX will be given on alternate days(39-55ml plasma/kg/session) 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patient having severe attack of myelitis.
2.MRC power in limb of grade ≤ 2.
3.Patients meet the criteria of NMOSD.
 
 
ExclusionCriteria 
Details  Haemodynamic instability.
Coagulopathy.
Not giving consent for plasma exchange.
Severe or uncontrolled infection.
EDSS ≥ 6 due to previous attack of NMOSD.
Patient refused to consent for the study. 
 
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 
To determine the efficacy of simultaneous PLEX and IVMPS as compared to IVMPS with add on PLEX as treatment of severe attack of acute myelitis of NMOSD.  Primary Outcome will be measured at three months of randomization. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the efficacy of simultaneous PLEX and IVMPS as compared to IVMPS with add on PLEX, one point improvement in EDSS will be categorised as clinically meaningful improvement.  Secondary Outcome will be measured at one and six months of randomization. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/01/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Background: 

NMOSD is an inflammatory disorder of central nervous system characterised  by optic neuritis and myelitis. As compared to Multiple Sclerosis ( MS), relapse of NMOSD is severe and without complete improvement leading to residual disability. The disability keeps on accumulating with further relapse. It is hence very important to treat acute relapse adequately and to use medications to prevent further relapse. Current approach for the treatment of acute attack of myelitis is to give IVMPS for 5 days and if there is inadequate response to add PLEX. This might result in loss of precious period awaiting therapeutic response of steroids . Studies have shown that there might be an compensatory stage where aquaporin-4 channels are internalized after complement and antibody attack. If adequately treated at this stage, cells may regain their function without undergoing necrosis. So, Time is Cord and early PLEX may improve the outcome.

Novelty: There is no RCT which have studied only myelitis  in NMOSD and compared the efficacy of  simultaneous PLEX and IVMPS as compared to IVMPS with add on PLEX as treatment of severe attack of acute myelitis of NMOSD. Many patients do not respond adequately to steroids and have residual disability. It is detrimental to wait for the response of steroids and then go for plasma exchange.  Some studies have shown time to PLEX has important role in the final outcome of the patients. So , we want to do a RCT comparing simultaneous plasma exchange (PLEX) and Intravenous methylprednisolone (IVMPS) versus IVMPS with add on PLEX in the treatment of acute severe myelitis of Neuromyelitis optica spectrum disorders (NMOSD).

Objectives: To determine the efficacy of  simultaneous PLEX and IVMPS as compared to IVMPS with add on PLEX as treatment of severe attack of acute myelitis of NMOSD at 3 month of randomization.

Methods: Patients who will present with acute severe myelitis and fulfilling the criteria of NMOSD will be enrolled in the study. The study will be Prospective, Randomized, Open label, Blinded Endpoint (PROBE) study.

Expected outcome: Based on evidence in form of case series , prospective small studies and our personal experience, we expect a beneficial effect in the outcome in form of improvement of Kurtzke Expanded Disability Status Scale (EDSS) in the intervention arm as compared to the control arm.
 
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