Whether you are a provider or patient, when you need trusted information to make confident health decisions, consider us.
Inclusion criteria:
Informal caregivers of adult patients-
Caregivers should –
Exclusion criteria:
PrimaryOutcome
During hospital stay–
– Caregivers(both study and control group)who are selected for the trial will receive training by trained healthcare professionals.
– Thesesessionwillcoverthefollowingareas:air wayan suctioning,nasogastric feeding and administration of medications, bowel and bladder care, maintaining personal hygiene and mobility.
Funding Agency. :
European Society of Intensive Care Medicine (ESICM).
Institution Responsible Project: St.Stephens Hospital,Delhi.
Total Centre – 3
Staff Details:-
Principal Investigator – Dr. Atul Phillips Global ICU award 2022
Co-Principal Investigator -Dr. Jeyaraj D pandian
Cite Recruitment Coordinator -Dr Megha & Mrs Neha
AVERT DOSE is a large, international, multi-centre clinical trial aiming to determine the most effective early mobility training program for patients following a stroke. The study employs an innovative adaptive trial design—specifically, a multi-arm, multi-stage, covariate-adjusted, response-adaptive randomised trial—to evaluate different evidence-informed mobility protocols delivered within 48 hours of stroke onset. The interventions are implemented by physiotherapists and nurses during the patient’s acute hospital stay or for up to 14 days, whichever comes first. Over 50 hospitals across Australia, Ireland, the UK, India (including CMC Ludhiana), Brazil, Singapore, and Malaysia are participating. The Christian Medical College and Hospital is serving as the National Coordinating Center for India.
The study has already recruited nearly 1,000 patients, with a goal of enrolling 1,400 by the end of this year. It is funded by the National Health and Medical Research Council (NHMRC) of Australia. The trial is led globally by Prof. Julie Bernhardt as Principal Investigator, with Dr. Jeyaraj Pandian serving as Co-Investigator on the grant. In India, Dr. Dimple Dawar serves as the National Project Manager.The Indian cohort includes approximately 14 physiotherapists and 15–16 nurses across seven hospitals, along with 8 blinded outcome assessors. The project highlights a strong international collaboration aimed at advancing evidence-based stroke rehabilitation practices.
Funding Agency: National Health and Medical Research Council (NHMRC), Australia.
Sponsor: The Florey Institute of Neuroscience and Mental Health,
245 Burgundy Street, Heidelberg VIC 3084
https://florey. edu. au
Number of Staff Involved at CMC Ludhiana: 8
Chief Investigator (India)– Dr Jeyaraj D Pandian
Indian Project Manager– Dr Dimple Dawar
Clinical Coordinator : Dr Dorcas Gandhi
Administrative Assistant- Mr Inderjit Singh
Dose Physiotherapists: Megha Chaudhary Khanna and Anmol Bhatia
Dose Nurse- Ms. Neha Chawla
Blinded assessor: Ms. Noor David
Associated Website: Florey.edu.au/research-group/avert-early-rehabilitation-research-group/
Registration anzctr.org.au – actrn1261900057134
Sponsor(s)
1.University of Calgary
1079, FMC, 29th Street NW Calgary, Alberta, Canada T2N2T9
2.The George Institute for Global Health The University of New South Wales Level 5, 1 King St Newtown, NSW 2042 Australia
BACKGROUND: In the year of 2019 there were 6.6 million deaths attributed to stroke, and it continues to be a major cause of death and disability worldwide. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke.
Summary of Proposed Research:
The ACT-GLOBAL study aims to identify treatment/s in patients with stroke associated with the highest chance of improving outcome.Currently, the ACT GLOBAL platform has 2 domains [Blood Pressure Domain (ENCHANTED3/MT) and Thrombolysis Domain (ACT-WHEN)].
In the Blood Pressure domain of ACT-GLOBAL, in patients with acute ischemic stroke with large vessel occlusion who receive endovascular thrombectomy the study intends to look at target blood pressure after endovascular thrombectomy which is associated with the good functional outcomeIn the THROMBOLYSIS (ACT-WHEN) domain of ACT-GLOBAL, participants with acute ischaemic stroke (AIS) where the randomized evidence to guide clinicians in their decisions over the balance of benefits vs. risk with IV tenecteplase dose for thrombolysis may be uncertain, will be randomized to receive low/standard dose/no treatment.
Core ACT-GLOBAL primary outcome
Functional dependence analyzed across the whole distribution of outcomes on the modified Rankin Scale (mRS) at Day 90.
Core ACT-GLOBAL secondary outcomes
Proportion of participants with mRS score of 0-1 at Day 90Proportion of participants with mRS score of 0-2 at Day 90
Health-related quality of life, as measured by the EQ-5D-5L at Day 90
Number of Staff:
Sponsors- Hamilton Health Sciences through its Population Health Research Institute 237 Barton Street East Hamilton, ON L8L 2X2 Canada
Grant-in-aid- Daiichi Sankyo Company, Limited
The EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation (ENRICH-AF) study is a global, multicenter, randomized controlled trial designed to evaluate the safety and efficacy of edoxaban—a direct oral anticoagulant—in preventing strokes among patients with atrial fibrillation (AF) who have previously experienced an intracranial hemorrhage (ICH). Participants are randomized to receive either edoxaban (60 mg or 30 mg daily, depending on clinical criteria) or standard medical therapy, which may include no antithrombotic treatment or antiplatelet monotherapy. The study employs an event-driven design, continuing until 123 confirmed primary efficacy events (composite strokes) occur. Recruitment was conducted across approximately 250–300 stroke centers worldwide, enrolling around 1,200 high-risk AF patients with a CHA₂DS₂-VASc score of ≥2 and a history of spontaneous or traumatic ICH .
Participants undergo follow-up visits every six months to monitor outcomes and adherence. As of the latest update, the study remains active but is no longer recruiting new participants . Specific information regarding the status of individual participants is confidential and not publicly disclosed. However, the study’s design ensures that all enrolled patients receive consistent monitoring and care throughout the trial period. The final results of ENRICH-AF are anticipated to provide critical insights into the optimal management of anticoagulation in AF patients with prior ICH, potentially influencing future clinical guidelines and improving patient outcomes.
Current Status on Site: 2 patients randomised
Website: https://data.phri.ca/50036/TrialMaster/Account/Login
CRC- Mr. Vishav Kumar
Objective- Hospital based stroke registries (HBSR) can support developing a network of hospitals treating stroke patients in different regions of India to generate evidence on access to stroke care in different treatment settings. The major objectives of this registry program is to generate reliable data on-
ICMR – National Centre for Disease Informatics and Research has developed web application for data capture for the project “HTA of National Stroke Care Registry Programme Development of Hospital Based Stroke Registries in Different Regions of India”. The objective is to provide a convenient and easy-to-use web-based data collection tool for the centres participating in this study, through which the users may store, retrieve and update information of patients and listing of cases due for follow-up.
Website: https://hbsr.ncdirindia.org/login
Current Status on Site: 905 patients entered into the registry since 2020.
Sponsor- Indian council of medical research (ICMR)
In this study we aim to study the effect of any genetic and/or biochemical risks on causing ICAD. Also, their role in stroke recurrence will be evaluated. Currently, the study is actively following 20 patients on CMC, Ludhiana site diagnosed with symptomatic ICAD or Acute Ischemic Stroke, with clinical assessments scheduled at three-month intervals. The collected data will provide insights into the natural history of ICAD and the impact of genetic and biochemical factors on disease outcomes. This ongoing research is expected to inform personalized medicine approaches and public health interventions aimed at reducing the burden of ICAD-related strokes in India.
Website: N/A
Current Status on Site:
20 Patients entered into this study
Name of Staff:
PI- Dr. Rajeshwar Sahonta
CRC- Mr. Vishav Kumar
Funding Agency: Indian Council of Medical Research, New Delhi- ICMR
Project Overview:
The INDIA-EMS project is an implementation research study, a National Health Research Priority Programme (NHRP), focused on creating a high-quality, patient-centered integrated emergency care model. This project aims to develop a scalable model of high-quality patient-centric integrated emergency care system to achieve 80% population coverage in the selected districts of India. This project targets specific districts in India, including Ludhiana (Punjab), Puducherry, Vidisha (Madhya Pradesh), Puri (Odisha), and Vadodara (Gujarat), focusing on condition areas such as trauma & burns, stroke, STEMI, maternal emergencies (like PPH and Pre-eclampsia), neonatal emergencies, Acute Respiratory Infections (ARI), snake bite, and poisoning. Under the leadership of Dr. Jeyaraj D Pandian, Principal Investigator, INDIA-EMS, we conducted baseline assessments. These included Health Facility Assessment Tools (HFAT) across 50 facilities (5 DH/SDH, 16 CHC, 29 PHC), ambulance service evaluations of 56 vehicles, and community surveys with 5,963 participants. These surveys identified gaps in current emergency care. We also collected qualitative data through 37 in-depth interviews and 6 focus group discussions with various personnel. Competency assessments of medical and nursing officers were performed, and emergency medical conditions at District Hospitals (DHs) were evaluated. We have also trained 150 SSF police officers in Basic Life Support (BLS) and Cardiopulmonary Resuscitation (CPR), and provided snake bite treatment protocol and triage training for Medical Officers in DHs.
Based on these assessments, we have started community awareness campaigns to address knowledge gaps. We have procured essential medical equipment and are planning its distribution to improve facility capabilities. Model ‘0’ of the INDIA-EMS project includes community-level actions like awareness programs, training police officers as first responders, training ambulance EMTs on emergency protocols, and developing pre-hospital notification systems. Health facility strengthening involves staff training, developing and implementing clear operational workflows for emergencies, promoting staff recruitment, and providing essential equipment and drugs. These efforts have informed our current validation study, which will evaluate new diagnostic tools for prehospital stroke care. The INDIA-EMS project aims to develop a scalable model for integrated emergency care, targeting 80% population coverage in the selected districts. The study’s findings will assess feasibility, acceptability, cost, and effectiveness, and will be shared nationally to help scale up the optimized model.
| Designation | Name | Contact number | ||
|---|---|---|---|---|
| Project Research Scientist – I Non Medical | Dr. Melkey Stephen Bunyan | 8185972615 | [email protected] | |
| Project Research Scientist – I Non Medical | Mr. Nicolas Naorem | 8459003240 | [email protected] | |
| Project Technical Support – III (Project Manager) | Hasneet Kaur Hora | 8427325252 | [email protected] | |
| Project Technical Support – III (Statistician) | Ashly P Koshy | 6282973695 | [email protected] | |
| Project Nurse II | Lovedeep Kumar | 8882083775 | [email protected] | |
| Project Nurse II | Mehrun Nisha | 8699849700 | [email protected] | |
| Project Nurse II | Pooja | 9877493466 | [email protected] |
Website: indians.icmr.org.in
Recruitment progress includes:
The trial is led globally by Dr. Raed Joundi (Principal Investigator), with Co-PIs Dr. Mike Sharma and Dr. Salim Yusuf. In India, Dr. Jeyaraj Pandian and Dr. Denis Xavier serve as National Leaders and and Dr Megha Khanna (PT) serves as the Indian Project Manager.
Funding Agency: Population Health Research Institute (PHRI), Canada.
Sponsor: Population Health Research Institute, Hamilton, Canada
Registration: CTRI/2023/07/054778
Associated Website: https://phri.ca
Title of the Research Project: Establishment of the Indian Stroke Clinical Trial Network Phase II( INSTRuCT Network Phase II)
Objectives
1.To continue an Indian Stroke Clinical Trial Network (INSTRuCT) as phase 2 with 4 new trials. 2.To conduct simple pharmacological and non-pharmacological stroke clinical trials in our country. 3. To made to make the network self-sufficient during the next 5 yearsThe four approved proposals planned in phase 2 are:
i. Randomised Trial of Biosimilar TNK versus TPA during Endovascular Therapy for Acute Ischemic StrokeDue to Large Vessel Occlusions. (RE-OPEN). (PI: Dr Rohit Bhatia, All India Institute of Medical Sciences,New Delhi)
ii. .Indian Trial of Tranexamic Acid in Non-traumatic Intracerebral Haemorrhage. (INTRINSIC TRIAL) (DrJeyaraj Durai Pandian,Christian Medical College,Ludhiana
iii. Medical Application based Post Stroke care Strategy for survivors and their caregivers: A Randomized Controlled Trial. (MOBILITY) (Dr Dheeraj Khurana, Post Graduate Institute of Medical Education and Research, Chandigarh)
iv. A Randomized Trial of Long-Term Dual Versus Single Antiplatelet Therapy in Patients with Intracranial Atherosclerotic Disease (STENOSIS) (PI: Dr Rohit Bhatia, All India Institute of Medical Sciences, New Delhi
Staff Details:
PI: Dr Jeyaraj D Pandian
COPI: Dr Rajeshwar Sahonta
Project Manager: Dr Shweta Jain Verma, Dr Deepti Arora
Helpdesk Executive: Ms Kanchan Batra
Accounts Executive: Mr Inderjit Singh
Statistician: Mrs Arya Devi K S
IT Executive: Mr. Ishnoor Singh
Funded by: Indian Council of Medical Research. (ICMR)
Trial website: https://instructnetwork.in/
Objective: To assess whether tranexamic acid improves outcome in adult patients with spontaneous intracerebral haemorrhage.Trial Design: Indian trial of tranexamic acid in spontaneous intracerebral haemorrhage (INTRINSIC STUDY) will be a multicentre, randomized, open-label, clinical trial. The participants will be randomized into two groups in a 1:1 ratio using a central database of INSTRuCT central online randomization. The baseline characteristics will be adjusted to stroke severity using NIHSS score and the volume of haematoma. Patients admitted with ICH and presenting within 4.5 hours in the intervention arm will receive 2grams of TXA intravenously in 100 ml normal saline over 45 minutes.
Outcome assessment
Primary Outcome
1)Death at day 7
Secondary Outcome
1) Radiological (CT scan): Change in hematoma volume from baseline to 24 hr scan, hematoma location, and new infarction.
2) Neurological impairment (NIHSS) at day 7 (or discharge if sooner).
3) Dependency using the seven-level modified Rankin Scale (mRS) at day 90
4) Quality of Life (EQ-5D) at days 90.
Status:-Ongoing
Total Recruited Patients:- 87 Patients
Staff Details:
PI: Dr Jeyaraj D Pandian
COPI: Dr Rajeshwar Sahonta
Project Manager: Dr Shweta Jain Verma, Dr Deepti Arora
Helpdesk Executive: Ms Kanchan Batra
Accounts Executive: Mr Inderjit Singh
Statistician: Mrs Arya Devi K S
IT Executive: Mr. Ishnoor Singh
Funded by: Indian Council of Medical Research. (ICMR)
Trial website: https://instructnetwork.in/
Objectives: Primary objective: To compare the impact of use of medical application-based care in addition to routine post stroke care strategy versus routine post stroke care strategy alone in preventing the post stroke complications (aspiration pneumonia, bedsores, catheter associated urinary tract infection (CAUTI), shoulder pain, deep vein thrombosis (DVT)) among stroke survivors
Secondary objectives: To compare the impact of use of medical application-based care addition to routine post stroke care strategy versus routine post stroke care strategy alone in preventing other post stroke complications among stroke survivors to compare the quality of life of stroke survivors between two groups. To compare their caregivers’ stress between two groups. To compare the cost effectiveness between two groups.
Status:-Ongoing
Total Recruited Patients:- 15 Patients
Staff Details:
PI: Dr Jeyaraj D Pandian
COPI: Dr Rajeshwar Sahonta
Project Manager: Dr Shweta Jain Verma, Dr Deepti Arora
Site Coordinators: Ms Pinky Mahey, Mr Akash Sharma
Helpdesk Executive: Ms Kanchan Batra
Accounts Executive: Mr Inderjit Singh
IT Executive: Mr. Ishnoor Singh
Statistician: Mrs Arya Devi K S
Funded by: Indian Council of Medical Research. (ICMR)
Trial website: https://instructnetwork.in/
Objectives: Primary objectives:
Secondary objectives:
Status:Terminated
Total Recruited Patients:- 10 Patients
Staff Details:
PI: Dr Jeyaraj D Pandian
COPI: Dr Rajeshwar Sahonta
Project Manager: Dr Shweta Jain Verma, Dr Deepti Arora
Site Coordinators: Ms Pinky Mahey, Mr Akash Sharma
Helpdesk Executive: Ms Kanchan Batra
Accounts Executive: Mr Inderjit Singh
IT Executive: Mr. Ishnoor Singh
Statistician: Mrs Arya Devi K S
Funded by: ICMR
Trial website: https://instructnetwork.in/
Primaryobjectives
1.To assess if long-term (12 months) dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is superior to aspirin and placebo in preventing recurrent stroke or TIA among patients with recent ischemic stroke due to symptomatic ICAD.
2. To assess if long-term (12 months) DAPT with aspirin and clopidogrel is safe when compared to aspirin and placebo in terms of any ICH, Symptomatic ICH or major systemic or minor bleeding among patients with recent ischemic stroke or TIA due to symptomatic ICAD as defined using GUSTO classification.
Secondary objectives: To assess if composite end point of stroke, MI or death to cardiovascular cause is reduced among patients with long-term DAPT with aspirin and clopidogrel versus aspirin and placebo among patients with recent ischemic stroke or TIA due to symptomatic ICAD.
Efficacy outcomes: Primary outcomes
1. Recurrent Ischemic stroke or TIA at the end of 12 months.
2.Any ICH, major or minor systemic bleeding at the end of 12 months
Secondary outcome: Composite of any stroke, MI or death at the end of 12 months
Status:- Stopped
Total Recruited Patients:- 0 Patient
Staff Details:
PI: Dr Jeyaraj D Pandian
COPI: Dr Rajeshwar Sahonta
Project Manager: Dr Shweta Jain Verma, Dr Deepti Arora
Site Coordinators: Ms Pinky Mahey, Mr Akash Sharma
Helpdesk Executive: Ms Kanchan Batra
Accounts Executive: Mr Inderjit Singh
IT Executive: Mr. Ishnoor Singh
Statistician: Mrs Arya Devi K S
Funded by: World stroke organisation
Project Overview
The ATTEND-2 project is an app-based telerehabilitation platform currently being developed at Christian Medical College, Ludhiana (CMCL). The core concept involves delivering context-specific, evidence-based upper limb rehabilitation exercises for stroke survivors. Designed for home use, the platform empowers family members and caregivers to assist with guided therapy sessions, bridging gaps in access to post-stroke rehabilitation—especially in rural and under-resourced regions of India.
As of 2025, the ATTEND-2 app has successfully completed its first round of acceptability testing with stroke survivors and caregivers. Feedback gathered through this survey is being used to refine and improve the app’s usability, cultural relevance, and therapeutic content. Updates to the platform are currently underway, with the goal of optimizing user engagement and ensuring clinical effectiveness in diverse real-world settings.
Staff Details
Principal Investigator: Prof. Dorcas BC Gandhi
Co PI: Dr Jeyaraj D Pandian
Project Manager: Dr Rinita Mascarenhas
Research Assistant: Dr Anuj G Nair
Funded by: World stroke organization, Future stroke leader program
Overview
The CAREMAP project is an initiative designed to evaluate and improve the quality of stroke rehabilitation services in India and Brazil, aligned with the standards set by the World Stroke Organization’s Future Stroke Leader Program (WSO FSLP). This initiative addresses the urgent need for equitable access to evidence-based stroke rehabilitation, especially in low-resource settings where rehabilitation services are often sparse, fragmented, or undocumented. Given India’s diversity in population, geography, and healthcare infrastructure, it serves as an ideal context to investigate region-specific barriers and develop targeted strategies for scalable, system-level improvements.
The project comprises three distinct phases. Currently in Phase 1, the project is focused on evaluating the adherence of rehabilitation services to WSO quality standards through structured quantitative audits and qualitative interviews at two selected centers in India and Brazil, stratified based on the Human Development Index (HDI). This foundational phase will inform subsequent stages that involve a comprehensive gap analysis, and the co-development of an implementation strategy tailored to context-specific needs and challenges identified through the initial assessment.
Staff Details
Principal Investigator: Prof. Dorcas BC Gandhi
Research Associate: Dr Rinita Mascarenhas
Funded by: Indian Association of Physiotherapy (IAP)
Overview
The SMULS trial aims to evaluate the effectiveness of a sensorimotor exercise regime tailored for patients experiencing upper limb deficits during the acute in-hospital phase after a supratentorial stroke. Upper limb impairment significantly impacts post-stroke quality of life and functional independence. This study implements a structured, evidence-based intervention targeting sensorimotor recovery, with the goal of enhancing motor function and promoting neuroplasticity during this critical early phase of stroke rehabilitation.
Currently, the trial has successfully recruited 10 participants. Ongoing recruitment will strengthen the study’s findings and potentially inform standardized clinical protocols for early upper limb rehabilitation in stroke survivors. The results are expected to contribute to a growing body of evidence supporting early sensorimotor-based interventions and improve outcomes in resource-limited hospital settings.
Staff Details
Principal Investigator: Prof. Dorcas BC Gandhi
Tittle: Contextualized clinical practice guidelines for motor rehabilitation after stroke in India- The CLAIM study
Funded by: Society of Indian Physiotherapits
Project Overview:
The CLAIM study is an initiative to develop contextualized clinical practice guidelines (CPGs) for motor rehabilitation following stroke in India. While international guidelines exist, they often fail to account for resource variability, cultural considerations, and system-level constraints faced in Indian healthcare settings. This project aims to bridge that gap by synthesizing global evidence, integrating stakeholder perspectives, and adapting recommendations to align with the realities of practice in low-resource environments.
The study adopts a multi-phase, mixed-methods approach, beginning with a systematic review of existing guidelines, followed by expert consensus-building through Delphi rounds, and validation with frontline clinicians and stroke survivors. This study holds the potential to standardize post-stroke motor rehabilitation across diverse settings in India and support policy-level advocacy for improved stroke care.
Staff Details
Principal Investigator: Prof. Dorcas BC Gandhi
Sponsor- Janssen Research & Development
The LIBREXIA-STROKE study is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of milvexian, an investigational oral Factor XIa inhibitor, for preventing recurrent ischemic strokes in patients who have recently experienced an acute ischemic stroke or high-risk transient ischemic attack (TIA). Participants aged 40 years and older are randomized to receive either milvexian 25 mg twice daily or placebo, in addition to standard single or dual antiplatelet therapy, for up to 41 months. The primary endpoint is the time to first occurrence of ischemic stroke, with key secondary outcomes including composite cardiovascular events such as myocardial infarction and cardiovascular death. The study aims to enroll approximately 15,000 participants globally and is expected to be completed by December 2026.
As of the latest update, approximately 50% of the targeted patient enrollment in India has been achieved, reflecting significant progress in the country’s contribution to this global study. This milestone underscores India’s pivotal role in advancing research on novel antithrombotic therapies aimed at reducing the risk of recurrent strokes without increasing bleeding complications. The data gathered from Indian participants will be instrumental in assessing the efficacy and safety of milvexian across diverse populations, potentially informing future stroke prevention strategies worldwide.
Current Status on Site: 4 patients randomised
Name of Staff:
PI- Dr. Jeyaraj D. Pandian
Co-I- Dr. Rajeshwar Sahonta
CRC- Mr. Vishav Kumar, Ms. Pinky Mahey
Sponsor- Sponsor Name: Novartis Pharma AG or its affiliates outside of the EEA (where applicable)
The REMODEL I and II trials (ClinicalTrials.gov Identifiers: NCT05147220 and NCT05156281) are Phase 3, randomized, double-blind, double-dummy, parallel-group studies designed to compare the efficacy and safety of remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, with teriflunomide in patients with relapsing multiple sclerosis (RMS). Each trial comprises a Core Part lasting up to 30 months, followed by an open-label Extension Part of up to 5 years, where all eligible participants receive remibrutinib. The primary endpoint is the annualized relapse rate (ARR), with secondary endpoints including confirmed disability progression, MRI lesion activity, serum neurofilament light chain levels, and the proportion of participants achieving no evidence of disease activity (NEDA-3).
Both studies aim to enroll approximately 800 participants globally and are currently recruiting. An interim analysis is planned on pooled 6-month MRI data from a subset of at least 200 participants. The trials are expected to complete by October 30, 2030 . Remibrutinib’s mechanism of action involves selective inhibition of BTK, reducing the activation of B cells and innate immune cells, which may offer a novel approach to modulating immune responses in RMS.
Website:
https://login.imedidata.com/login?service=https%3A%2F%2Fwww.imedidata.com%2F
Current Status on Site: 1 patient onging
Name of Staff:
PI- Dr. Jeyaraj D. Pandian
Co-I- Dr. Vineeth Jaison
EDSS Rater: Dr. Rajeshwar Sahonta
CRC- Mr. Vishav Kumar
Sponsor :- Regeneron Pharmaceuticals Inc.
CRO:- Parexel
PI:- Dr. Vineeth Jaison
Study Design: This is a multinational, randomized, double-blind, placebo-controlled trial in patients with symptomatic gMG who have a confirmed clinical diagnosis along with anti-AChR antibodies or anti-LRP4 antibodies. The study includes an approximately 5-week screening period, a 24-weedouble-blind placebo-controlled DBTP, a 28-week double-blind ETP, a 68-week OLTP, and a post-treatment follow-up period (FUP) until 52 weeks after the last dose of study treatment. Patients will continue on their regional standard of care treatment for gMG duringscreening and during the study. Combination = pozelimab 200 mg Q4W + cemdisiran 200 mg Q4W All treatments are administered SC throughout the study and are added onto the patient’s existing treatment, as applicable, for MG During the FUP, patients with a compelling medical need may be eligible for treatment with combination or cemdisiran monotherapy after discussion with the sponsor Once the number of patients randomized to the pozelimab monotherapy arm reaches approximately 40 patients, thenfurther enrollment of patients, if applicable, will continue into the remaining 3 arm.
Primary Objective
The primary objective of the study is to evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG.
Website:-
https://auth.eclinicalcloud.net/u/login/
Staff Involved :-
PI- Dr. Vineeth Jaison
Co-PI- Dr. Jeyaraj D. Pandian
Site Coordinator- Mr. Akash , Miss Pinky Mahey
Rater:- Dr. Sandeep Kaur
Sponsor: F. Hoffmann-La Roche Ltd
CRO: IQVIA
Trial website:
https://forpatients.roche.com/en/trials/autoimmune-disorder/multiple-sclerosis/study-to-evaluate-the-efficacy-and-safety-of-fenebrutin-78378.html
Number of Staff involved: 4
PI: Dr Jeyaraj D Pandian
COPI: Dr Vineeth Jaison
Site Coordinators: Ms Pinky Mahey
Ongoing patient: 1 (followup phase)
This clinical trial, a Phase III study (GN42272), is investigating the efficacy and safety of fenebrutinib compared to teriflunomide in adult patients with relapsing multiple sclerosis (RMS). It’s a multicenter, randomized, double-blind, double-dummy, parallel-group trial, meaning patients are randomly assigned to one of the two treatment groups (fenebrutinib or teriflunomide) without knowing which they are receiving. The study aims to assess the effectiveness of fenebrutinib in reducing disability progression and relapse rates in RMS patients compared to teriflunomide.
Whether you are a provider or patient, when you need trusted information to make confident health decisions, consider us.
