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CTRI Number  CTRI/2023/12/060404 [Registered on: 01/12/2023] Trial Registered Prospectively
Last Modified On: 28/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   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)  
Name  Dr. Dharmesh Shah 
Designation  Assistant Medical Director  
Affiliation  Pharmazz India Private Limited  
Address  H-6,Site-C,Surajpur Industrial Area, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  8800015065  
Fax    
Email  dharmesh.shah@pharmazz.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish S Lavhale  
Designation  Managing Director  
Affiliation  Pharmazz India Private Limited  
Address  H-6,Site-C,Surajpur Industrial Area, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  9873847397  
Fax    
Email  manish.lavhale@pharmazz.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dharmesh Shah 
Designation  Assistant Medical Director  
Affiliation  Pharmazz India Private Limited 
Address  H-6,Site-C,Surajpur Industrial Area, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  8800015065  
Fax    
Email  dharmesh.shah@pharmazz.com  
 
Source of Monetary or Material Support  
Pharmazz India Private Limited H-6,Site-C,Surajpur Industrial Area, Greater Noida, UtterPradesh,201307 
 
Primary Sponsor  
Name  Pharmazz India Private Limited  
Address  H-6,Site-C,Surajpur Industrial Area, Greater Noida, UtterPradesh,201307 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tushar Patil  Acharya Vinoba Bhave Rural Hospital   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 
8377994629

drsushmal123@gmail.com 
Dr Sikandar GokulDass Adwani  Radiant Superspeciality Hospital  Subnis Plot, Kalyan Nagar Square,Amravati-444606
Amravati
MAHARASHTRA 
8446015115

sikandaradwani@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
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.  Approved 
KAKATIYA INSTITUTIONAL ETHICS COMMITTEE Warangal-506002, Telangana,   Approved 
Lalitha SuperSpecialities Hospital Ethics Committee  Approved 
METRO SPECIALITY INSTITUTIONAL ETHICS COMMITTEE  Approved 
Radiant Superspeciality Hospital Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (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.

 
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