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CTRI Number  CTRI/2024/07/070459 [Registered on: 11/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assesment of Safety and efficacy of the drug called sovateltide in patients with acute cerebral ischemic stroke patients 
Scientific Title of Study   Safety and efficacy of sovateltide in acute cerebral ischemic stroke patients at a tertiary care centre-a double blinded block randomised placebo controlled 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  Shobana Sundaram 
Designation  Assistant Professor, Neurology 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Neurology, Pondicherry Institute of Medical Sciences, Kalapet, Puducherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  7639505001  
Fax    
Email  shobanadmneuro@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shobana Sundaram 
Designation  Assistant Professor, Neurology 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Neurology, Pondicherry Institute of Medical Sciences, Kalapet, Puducherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  7639505001  
Fax    
Email  shobanadmneuro@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shobana Sundaram 
Designation  Assistant Professor, Neurology 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Neurology, Pondicherry Institute of Medical Sciences, Kalapet, Puducherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  7639505001  
Fax    
Email  shobanadmneuro@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences Ganapathichettikulam, Kalapet, Puducherry, India Pin code : 605014 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Kalapet, Puducherry - 605014 
Type of Sponsor  Private medical college 
 
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 Shobana Sundaram  Pondicherry Institute of Medical Sciences  Department of Neurology and Medicine, Medical ICU, Male and female medical wards
Pondicherry
PONDICHERRY 
7639505001

shobanadmneuro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PLACEBO - NORMAL SALINE  Three doses of 10ml Normal saline at an interval of 3 hours of day1, day 3 and day 6 (total dose : 30ml/day). This will be administered through intravenous route. Total of 3 doses per day. 
Intervention  SOVATELTIDE  Three doses of sovateltide at an interval of 3 hours on day 1, day 3 and day 6 (total dose of 0.9 µg/kg/day). Intravenous route at a dose of 0.3 µg/kg (each dose) administered as an intravenous bolus over 1 min. Total of 3 doses per day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients presenting within 24 hours from the onset of stroke symptoms.
2.Stroke patients with modified rankin score of 3-4 and national institute of stroke scale score of 5-25
3.Stroke patients with radiological confirmation of stroke. 
 
ExclusionCriteria 
Details  1.Patients with intracranial haemorrhage.
2.Patient with ischemic heart disease
3.Chronic liver and renal failure
4.Patients who are planning for Endovascular therapy.
5.Patients with sepsis.
6.Pregnant women.
7.Breast feeding women.
8.Stroke mimics 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement In Mondified Rankin score and NIHS score  Basline, 15th day and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects of Sovateltide  90 day 
 
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 4 
Date of First Enrollment (India)   22/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Stroke is the second most common cause of death in our country and is also an important factor which causes a serious long-lasting disability where care giver’s burden is very high. The foremost treatment strategies available currently for acute cerebral ischemic stroke includes thrombolysis by administrating tissue plasminogen activator (tPA) and mechanical thrombectomy. However, both these strategies have a short time window. Limitations of time, risk of bleeding and involvement of larger blood vessels for thrombectomy restricts current treatment to only about 5% of patients. Sovateltide or IRL-1620 is a synthetic analog of endothelin 1 (ET-1). Sovateltide is a selective agonist of endothelin B (ETBRs). ETBRs play an important role in neural cell survival and proliferation. Sovateltide, administered intravenously following acute cerebral ischemic stroke increased cerebral blood flow, had anti-apoptotic activity and produced neurovascular remodelling. Hence, this study is designed to determine the efficacy of Sovateltide along with standard of care stroke protocol in improving the 90th day quality of life in acute cerebral ischemic stroke patients presenting within 24 hours of stroke onset as measured using modified rankin scale (MRS) and national institute of health stroke scale (NIHSS) compared to standard of care stroke protocol alone. Our sample size is 60 with 30 patients in the treatment group and 30 patients in the placebo group respectively. Patients who fulfil the inclusion criteria will be randomised into both the arms. Treatment group will receive three doses of sovateltide (each dose 0.3 µg/kg) administered as an intravenous bolus over 1 min at an interval of 3 hours on day 1, day 3 and day 6 (total dose of 0.9 µg/kg/day). The other group will receive a matching placebo at the same dose and on the same dose intervals. The study duration for each patient will be 3 months (90 days), which includes three follow-up visits: visit 1 (day 15, screening/baseline measurements/treatment/assessment), visit 2 (day 90 for final MR score/ NIHS score (day 90 ± 5 days, assessment). All patients will be monitored closely throughout hospitalization and will be followed-up for 90 days from randomization.

 
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