| 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
|
|
|
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
|
|
|
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. |