sovateltide Injection for the treatment of acute cerebral ischemic stroke
Scientific Title of Study
A prospective, multicentric, randomized, double-blind, parallel, phase IV study to assess
the safety and efficacy of TycamzziTM (sovateltide) in patients with acute cerebral
ischemic stroke
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
Sovateltide/CT-4.1/2022,Version 1.0/15 May 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Jawaharlal Nehru Medical College,
Datta Meghe Institute of Higher Education and Research,
Sawangi (Meghe)-442004, India
Wardha MAHARASHTRA
9021810293
tushar.neuro@gmail.com
Dr Praveen Kumar S
Bangalore Medical College and Research Institute
Department of Neurology, Bangalore Medical College & Research Institute, Super speciality Hospital(PMSSY)Victoria Hospital Campus, KR Market, Bangalore, Karnataka-560002,India Bangalore KARNATAKA
9448685155
dmpraveen@gmail.com
Dr Birinder Singh Paul
Dayanand Medical College and Hospital
Research and Development Centre Tagore Nagar Civil Lines Ludhiana PUNJAB
9878045330
drbirinder06@yahoo.co.in
Dr Lakshya Jyoti Basumatary
Excelcare Hospitals
Room no- 112, 1st floor Neuro Department OPD Block (Part-A), Apollo Excelcare Hospital,
(A unit of Asclepius Hospitals and Health Care Pvt. Ltd.) Near Ganesh Mandir, Boragaon, NH-37, Guwahati, Assam- 781033
Bongaigaon ASSAM
9954480668
drbasumatary@gmail.com
Dr Raghavendra BS
Father Muller Medical College Hospital
Department of Neurology
Father Muller Road, Kankanady,
Mangalore-575002, India.
Dakshina Kannada KARNATAKA
9986144799
padayappa4u@gmail.com
Dr Upputuri Aruna Kumari
Guntur Medical College & Government General Hospital
Department of neurology
3rd floor, Podila Prasad building
Govt. General Hospital Medical College,Guntur-522001
Guntur ANDHRA PRADESH
9440262988
arunakumari.u@gmail.com
Dr TCR Ramakrishnan
KG Hospital & Post Graduate Medical Institute & Research Centre,
Door No.-5, Govt. Arts College Road,
Coimbatore-641018,Tamil Nadu, India
Coimbatore TAMIL NADU
9443365792
kgneuro@gmail.com
Dr Swapnil Samadhiya
Kshetrapal Hospital Multispeciality and Research Centre
Department of Neurology
C-170,Makarwali Road,C Block,
Panchsheel Nagar, Ajmer-305004,
Jaipur RAJASTHAN
8107826377
swapnil.shrul@gmail.com
Dr Vijaya Pamidimukkala
Lalitha Super specialities Hospital Pvt. Ltd.
Department of Neurology, Ground Floor, Lalitha Superspecialities Hospital Pvt. Ltd.
Kothapet,Guntur-522001
Guntur ANDHRA PRADESH
9440808621
drvijaya.lssh@gmail.com
Dr Arvind Kumar Kankane
Maharani Laxmi Bai Medical College & Associated Hospital
Department of Neurology
Super specialty Block
Kanpur Road, Jhansi-284128 Jhansi UTTAR PRADESH
9838072655
drarvind_neuro@rediffmail.com
Dr Naveen Korivi
Mahatma Gandhi Memorial Hospital
Department of Neurology, Room No-196, Ground Floor Mahatma Gandhi Memorial Hospital, Sherpura, Warangal-506002, Telangana, India. Warangal TELANGANA
7997738351
nknaveenkorivi@gmail.com
Dr Sushma Sharma
Metro Heart Institute with Multispeciality
Room Number-2, Ground Floor,
Department of Neurology
Nirman Kunj, ADB PWD Colony,Sector 16A,
121002
Faridabad HARYANA
Drug Trial Ethics Committee,Dayanand Medical College and Hospital
Approved
ETHICS COMMITTEE GMC and GGH Guntur
Approved
Ethics Committee of BMCRI, Bangalore Medical College and Research Institute, Fort, K.R. Road, Bengaluru-560002, Karnataka
Approved
Ethics committee, M.L.B Medical college
Approved
Father Muller Institutional Ethics Committee,
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee of DMIHER, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra
Approved
Institutional Ethics Committee,
Approved
Institutional Ethics Committee,KG Hospital & Post Graduate Medical Institute & Research Centre, Door No.- 5, Govt. Arts College Road, Coimbatore - 641018, Tamil Nadu, India.
(1) ICD-10 Condition: I635||Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Normal Saline
Three doses of Normal Saline (Equal volume) will be administered as an IV bolus over one minute, at an interval of 3 hours ± 1 hour on day 1.
The dose will be repeated on day 3 and day 6 post-randomization.
Intervention
Sovateltide injection containing 30 µg
Sovateltide(Sovateltide + Standard treatment), It is a lyophilized product Sovateltide injection containing 30 µg of Sovateltide in a 5.0 mL vial. Three doses of Sovateltide (each dose of 0.3 mcg/kg body weight) will be administered as an IV bolus over one minute, at an interval of 3 hours ± 1 hour on day 1. The dose will be repeated on day 3 and day 6 post-randomization. Sovateltide will be administered as an IV bolus dose over one minute within 24 hours of the stroke onset.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
78.00 Year(s)
Gender
Both
Details
1. Adult males or females aged 18 years through 78 years (have not had their 79th birthday).
2. Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure.
3. Stroke is ischemic in origin and radiologically confirmed Computed Tomography(CT) scan or diagnostic magnetic resonance imaging(MRI) before enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
4. Cerebral ischemic stroke patients presenting within 24 hours after onset of symptoms with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score >5 (NIHSS Level of Consciousness (1A) score must be < 2). This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke.
5. The patient is <24 hours from the time of stroke onset when the first dose of Sovateltide therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self-reported to be normal.
6. Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits.
ExclusionCriteria
Details
1.Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
2. Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score more than or equal to 2).
3. Evidence of intracranial hemorrhage (intracerebral hematoma,
intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, an acute or chronic subdural hematoma on the baseline CT or MRI scan.
4. Known pregnancy.
5. Confounding pre-existing neurological or psychiatric disease.
6. Concurrent participation in any other therapeutic clinical trial.
7.Evidence of any other major life-threatening or serious medical
condition that would prevent completion of the study protocol,
impair the assessment of outcome, or in which Sovateltide therapy
would be contraindicated or might cause harm to the patient.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Any adverse events (AEs) or serious adverse events (SAEs)
within 90 days post-randomization
Secondary Outcome
Outcome
TimePoints
The proportion of cerebral ischemic stroke patients with a change in modified Rankin Scale (mRS) score of more than & equal to 2
at day 90 post-randomization
The proportion of cerebral ischemic stroke patients with a change in National Institute of Health Stroke Scale (NIHSS) score more than & equal to 6
at day 90 post-randomization
The proportion of cerebral ischemic stroke patients with a Barthel index (BI) score more than & equal to 60
at day 90 post-randomization
Change in NIHSS
at day 90 post-randomization
Change in mRS
at day 90 post-randomization
Change in BI
at day 90 post-randomization
Change in Quality-of-life as assessed by EuroQol-EQ-5D
at day 90 post-randomization
Change in Stroke-Specific Quality of Life (SSQOL)
at day 90 post randomization
The proportion of patients with recurrent cerebral ischemic stroke
within 90 days post randomization,
Number of deaths
within 90 days post-randomization
proportion of patients with radiographic or symptomatic Intra Cerebral Hemorrhage (ICH)
within 24 (± 6) hours of randomization
Change in Montreal Cognitive Assessment (MoCA) score
at day 90 post-randomization
Compare Alberta Stroke Program Early CT (ASPECT) Score for stroke severity & identify sites of ischemic lesions.
at baseline
Target Sample Size
Total Sample Size="160" Sample Size from India="160" 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)
15/12/2023
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="6" 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
This is a prospective, multicentric, randomized, double-blind, parallel, phase IV study to assess the safety and efficacy of TycamzziTM (sovateltide) in patients with acute cerebral ischemic stroke. A total of 160 patients (80 in each treatment arm) will be enrolled in the study. This protocol is designed to assess a novel first-in-class treatment for use in critical care and life-threatening condition of cerebral ischemic stroke with an unmet need and is of national interest. The enrolment period of the study will be approximately 15 months, and the total duration of the study will be approximately 18 months. For an individual patient, the duration of the study will be 3 months (90 days), including 3 study visits: visit 1/Day 1 (screening, randomization, baseline measurements, and treatment), Day 2 (measurements), Days 3 and 6 (measurements and treatment), visit 2/telephonic visit (Day 30 ±5), and visit 3/end of the study (Day 90 ± 7). At visit 1, a total of 160 patients will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria:
Group 1: TycamzziTM (sovateltide)+ Standard treatment
Group 2: Normal Saline (Dose: Equal volume) + Standard treatment
Sovateltide or Normal Saline will be administered as an intravenous (IV) bolus over one minute within 24 hours after the onset of stroke. In the Sovateltide group, three doses of Sovateltide (each dose of 0.3 mcg/kg body weight) will be administered as an IV bolus over one minute at an interval of 3 hours ± 1 hour on day 1, day 3, and day 6 (total dose/day: 0.9 µg/kg body weight). In the control group, three doses of an equal volume of normal saline will be administered as an IV bolus over one minute at an interval of 3 hours ± 1 hour on day 1, day 3, and day 6 post randomization. In both treatment groups, patients will be provided the standard stroke treatment. Standard treatment to be provided to the patients shall be the one used in the particular hospital setup. Each patient will be monitored closely for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.