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CTRI Number  CTRI/2018/12/016667 [Registered on: 13/12/2018] Trial Registered Prospectively
Last Modified On: 15/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the effect of PMZ-1620 in spinal cord injury patients. 
Scientific Title of Study   A Prospective, Multicentric, Randomized, Double Blind, Saline Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy along with Standard Supportive Care in Patients of Acute Spinal Cord Injury 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PMZ-1620/CLINICAL-2.3/2018, Version 2, Dated 05 July 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Manish S Lavhale  
Designation  Associate Director 
Affiliation  Pharmazz India Private Limited  
Address  Department of Research and Development 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  Mr Sunil Gulati  
Designation  Chief Operating Officer  
Affiliation  Pharmazz India Private Limited  
Address  Department of Research and Development H-6, Site-C, Surajpur Industrial Area, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  9811406340  
Fax    
Email  sunil.gulati@pharmazz.com  
 
Source of Monetary or Material Support  
Pharmazz India Private Limited, H-6, Site-C, Surajpur Industrial Area, Greater Noida UP 201307  
 
Primary Sponsor  
Name  Pharmazz India Private Limited  
Address  H-6, Site-C, Surajpur Industrial Area, Greater Noida 201307, Uttar Pradesh, India 
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 = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Harvinder Singh Chhabra  Indian Spinal injuries Centre  Vasant Kunj Marg, Opp Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
New Delhi
DELHI 		 01142255356

drhschhabra@isiconline.org 
Dr Subhasis Ghosh  IPGMER and SSKM Hospital   Department of Neurosurgery, Bangur Institute of Neurosciences, 8, Sambhunath Pandit Street Bhowanipore, Kolkata-700020
Kolkata
WEST BENGAL 		 9831096427

hodneurosurgerybin@gmail.com 
Dr Shah Waliullah  King Gorges Medical University   Department of Orthopedic Surgery, RALC Building, Nabiullah road
Lucknow
UTTAR PRADESH 		 9335716350

shahwali2008@gmail.com 
Dr Sameer Haveri  KLEs Dr. Prabhakar Kore Hospital and MRC  Nehru Nagar,
Belgaum
KARNATAKA 		 984433082

drsameerhaveri@gmail.com 
Dr Chandra Prakash Pal  Sarojini Naidu Medical College, Agra  Raja Mandi, Near Agra Medical college Agra, Central Library, Moti Katra, Mantola, Agra, Uttar Pradesh 282003
Agra
UTTAR PRADESH 		 9634031500

drcpotho@gmail.com 
Dr Aadil Shukat Chagla  Seth GS Medical College and KEM Hospital  Neurosurgery Department, ward No.-33, 2nd Floor, Old Building, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 		 9820776190

aadilchagla@kem.edu 
Dr Ravi P Dashputra  Seven Star Hospital  324, 1, Great Nag Rd, Jagnade square, Nandanvan, Nagpur, Maharashtra 440009
Nagpur
MAHARASHTRA 		 9823079739

ravidash123@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee, New Era Hospital, Central Avenue Road, near Telephone Exchange Chowk, Queta Colony, Near Jalaram Mandir, Nagpur-440008, Maharastra, India  Submittted/Under Review 
Ethics Committee, Rahate Surgical Hospital Rahate Surgical Hospital, 517, Kolba Swami Square, Old Mangalwari, Central Avenue Road Nagpur Nagpur Maharashtra - 440008 India  Approved 
Institutional Ethics Committee S.N Medical S N Medical College Raja Mandi Near Agra College Agra Central Library ,moti Katra Mantola Agra Agra Uttar Pradesh - 282003 India  Approved 
Institutional Ethics Committee, Institute of Medical Science, Banaras Hindu University, Varanasi- 221005, Uttar Pradesh  Submittted/Under Review 
Institutional Ethics Committee, Indian Spinal Injuries Centre (ISIC), Sector-C, Vasant Kunj, New Delhi-110070, India  Approved 
Institutional Ethics Committee, KLE University, JN Medical College, Nehru Nagar, Belgaum- 590010  Approved 
Institutional Ethics Committee, Research Cell Administrative Block, King Gorges Medical University, Lucknow- 226003  Approved 
Institutional Ethics Committee-l Seth GS Medical College and KEM Hospital, Mumbai. Acharya Donde Marg, Parel, . Mumbai 400 012. India Mumbai Mumbai City Maharashtra - 400012 India  Approved 
IPGMEandR Resaerch Oversight Committee IPGMEandR 244 Acharya J. C. Bose Road - Kolkata Kolkata West Bengal - 700020 India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, (2) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, (3) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IRL-1620 For Injection (PMZ-1620)   PMZ-1620 + Standard of care: Three doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 μg/kg body weight). PMZ-1620 will be administered as an intravenous bolus dose over 1 minute within 48 hours of the SCI onset. 
Comparator Agent  Normal Saline  Normal Saline (Dose: Equal volume) + Standard of care: Three doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization. Normal Saline will be administered as an intravenous bolus dose over 1 minute within 48 hours of the SCI onset. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Adult males or females aged between 18 to 75 years, both inclusive

2. Able to give consent for participation on their own or through their Legally Authorized Representative (LAR)

3.Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards

4. ISNCSCI Impairment Scale Grade "B", "C" or "D" based upon first ISNCSCI evaluation after arrival to the hospital is classified as motor or sensory incomplete

5. Willing and able to comply with the study Protocol

6. Female subject is either:
a. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation,bilateral oophorectomy or hysterectomy) or,

b. If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up
visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, OR A vasectomised partner OR abstinence

7. Able to receive the Investigational Product within 48 hours of injury

8. Neurological Level of Injury between C5-C8, T1-T12, L1- L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital

9. Patient with incomplete/partial damage/transaction as shown by CT or MRI scan

10. Patients with any other chronic conditions, who are stable with appropriate treatment 
 
ExclusionCriteria 
Details  1. Previous history related to spinal cord disease

2. Patient on ventilator or requires ventilator

3. Patient with pathological fracture of vertebral column
4. Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified as complete injury

5. One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination

6. Concomitant head injury with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)

7. Females who have a positive urine pregnancy test.

8. Body mass index (BMI) of ≥35 kg/m2 at screening

9. Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs

10. Patient having rheumatoid arthritis

11. Clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator

12. Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up.

13. Patients who are currently participating in a clinical trial with an investigational product or investigational device

14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of adverse events (AEs) and serious adverse events (SAEs)  03 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Statistically relevant changes in clinical progression of ASCI as measured by ISNCSCI
scoring 		 From baseline to 1, 2 and 3 months after treatment 
Statistically relevant changes in WISCI II Score  From baseline to 1, 2 and 3 months after treatment 
Statistically relevant changes in SCIM score  From baseline to 1, 2 and 3 months after treatment 
Statistically relevant changes in MRI/CT  From baseline and three months after treatment 
Statistically relevant changes in EMG  From baseline and three months after treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   25/12/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
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, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 therapy along with standard supportive care in patients with ASCI. Total 40 patients will be enrolled in this study. The enrolment period of the study will be approximately 12 months and total duration of the study will be approximately 15 months.For an individual patient, duration of the study will be 3 months (85-95 days), including 4 study visits: visit 1/Day 1 to Day 6 (screening/baseline/treatment visit), visit 2b/Day 30±5 (assessment visit), visit 3/Day 60±5 (assessment visit) and visit 4/End of Study/Day 90±5 (assessment and follow-up visit). Besides above visits, first 8 patients enrolled in this study will be evaluated for safety at Day 15 (visit 2a/Day 15±2 (assessment visit)). At visit 1, day 1, patients will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria:

Group 1: PMZ-1620 + Standard of care
Group 2: Normal Saline + Standard of care

Three doses of PMZ-1620 (each dose of 0.3μg/kg body weight) or Normal Saline (equal volume) will be administered as an IV bolus over one minute at an interval of 3±1 hours on Day 1, 3 and 6. There will be total of 9 doses over 3 days (0.9μg/kg body weight/day). In both treatment groups, patients will be provided the standard of care. Each patient will be monitored closely throughout his/her admission for the qualifying SCI and will be followed for 3 months from randomization. Each patient will be assessed for safety and efficacy parameters over 3 months from randomization at a clinic visit.
 
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