Acute Spinal Cord InjuryPhase 2NCT04054414
PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
A Phase 2 study testing Normal Saline along with standard treatment and PMZ-1620 along with standard treatment in people with Acute Spinal Cord Injury, run by Pharmazz, Inc. at 5 sites in India.
Trial summary
This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- Normal Saline along with standard treatment and PMZ-1620 along with standard treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesIndia
- Study dates
- 10 Jan 2019to Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females aged between 18 and 75 years inclusive
- Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)
- Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator)
- 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
- Willing and able to comply with the study Protocol
- Women must be of non-childbearing potential or surgically sterile or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
Show all 10Show fewer
- Able to receive the Investigational Drug within 48 hours of injury
- Neurological Level of Injury between C5-C8, T1-T12, L1-L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital
- Patient with incomplete/partial damage/transaction as shown by CT or MRI scan
- Patients with any other chronic conditions, who are stable with appropriate treatment
Who cannot join
- Previous history related to spinal cord disease
- Patient on ventilator or requires ventilator
- Patient with pathological fracture of vertebral column
- Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified as complete injury
- One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination
- 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)
Show all 14Show fewer
- Females who are breastfeeding or have a positive urine pregnancy test
- Body mass index (BMI) of ≥35 kg/m2 at screening
- Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
- Patient having rheumatoid arthritis
- The participant has a clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator
- Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder with hallucinations/delusions/schizophrenia)
- Patients who are currently participating in a clinical trial with an investigational drug or investigational device
- Patients who, in the opinion of the investigator, are otherwise unsuitable for this study
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ravi Kant contact
5 sites in 1 country
India5 sites, 5 recruiting
- Not yet recruiting
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, 590010
Sameer Haveri, +91 9844333082, drsameerhaveri@gmail.com
- Recruiting
Institute of Postgraduate Medical Education & Research and SSKM Hospital
Kolkata, 700020
Rajat Choudhuri, +91 9874660960, rajat.choudhuri@gmail.com
- Recruiting
King George's Medical University
Lucknow, 226018
Shah Waliullah, +91-9335716350, shahwali2008@gmail.com
- Recruiting
Rahate Surgical Hospital & ICU
Nagpur, 440008
Ravi P Dashputra, +91-9823079739, ravidash123@gmail.com
- Recruiting
Indian Spinal Injury Centre
New Delhi, 110070
H.S. Chhabra, +91 11 42255356, drhschhabra@isiconline.org
About this study
Official title: 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
This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.
Read the detailed description
Trauma is projected to be third largest killer in the developing world by 2020, with a large number of these injuries comprising of traumatic spinal cord injury. People with spinal cord injuries (SCI) are two to five times more susceptible to die than people without an injury. More than 80% cases of SCIs occur among young people between the ages of 20 and 45 years and majority of sufferers are male. In developed countries, the incidence of spinal injuries varies from 20 to 50 per million. Every year about 250,000 to 500,000 number of SCI cases are reported.
There are hidden stem cells in the brain, which becomes active following injury to the spinal cord. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the spinal cord to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic and anti-oxidant activity.
Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Normal Saline along with standard treatment, PMZ-1620 along with standard treatment
- Keywords
- Endothelin, Neurogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline along with standard treatmentDrug
Also called Vehicle
The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.
PMZ-1620 along with standard treatmentDrug
Also called Sovateltide (IRL-1620) along with standard treatment
PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | Patients will receive the best available standard of care. In control group, 3 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. Receives: Drug: Normal Saline along with standard treatment |
| PMZ-1620 | Experimental | Patients will receive the best available standard of care. In PMZ group, 3 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). Receives: Drug: PMZ-1620 along with standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PMZ-1620 related adverse events
The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
Measured: 90 days
Number of patients not receiving full treatment
Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.
Measured: 90 days
Secondary outcomes (5)
Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
Statistically relevant changes in clinical progression of ASCI as measured by ISNCSCI scoring at one, two and three months after treatment. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) or more commonly referred to as the ASIA Impairment Scale (AIS), is a universal classification tool for Spinal Cord Injury based on a standardized sensory and motor assessment. Ranges from A to E where A = Complete and no sensory or motor function is preserved and E = Normal sensory and motor functions
Measured: 90 days
Changes in walking index for spinal cord injury (WISCI) score
Statistically relevant changes in WISCI Score at one, two and three months after treatment. This test assesses the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It rank orders the ability of a person to walk 10 meter after a spinal cord injury from most to least severe impairment. A score from 0 to 20 is assigned, level 0: patient is unable to stand and/or participate in walking and level 20 patient ambulates with no devices, with brace and no assistance.
Measured: 90 days
Changes in Spinal Cord Independence Measure (SCIM) score
Statistically relevant changes in SCIM score at one, two and three months after treatment. Spinal Cord Independence Measure (SCIM) scale is used to measure the disability to specifically address the ability of SCI patients to perform basic activities of daily living independently. The SCIM scores range from 0 to 100 where where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
Measured: 90 days
Changes in MRI/CT
Changes in MRI/CT, before (baseline) and three months after treatment. Radiological evidence of transaction of spinal cord will be recorded by CT or MRI scan. In addition, edema, contusion, extent of spinal cord damage will be recorded.
Measured: 90 days
Changes in electromyography (EMG)
Changes in EMG, before (baseline) and three months after treatment. Changes in nerve conduction parameters are recorded from the peroneal, tibial, and sural nerves. The presence of spontaneous activity (SA), including fibrillation and positive sharp waves are recorded in muscle groups vastus medialis, iliopsoas, tibialis anterior, medial gastrocnemius, and lumbar paraspinals. A decrease in nerve conduction parameters are indicative to greater severity. A high degree of abnormal SA on electromyographic testing represents the presence of muscle membrane instability.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start10 Jan 2019
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In PMZ group, 3 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). In control group, 3 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. In both treatment groups, subjects will be provided the best available standard of care.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmazz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anil Gulati, Study chair, Pharmazz, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054414
- Sponsor's protocol ID
- PMZ-1620/CLINICAL-2.3/2017
- Other IDs
- CTRI/2018/12/016667
- Status last verified
- Jul 2025
- First submitted
- 10 Aug 2019
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be communicated and published as manuscript
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04054414
- Acronym / sponsor ID
- PMZ-1620/CLINICAL-2.3/2017
- Conditions
- Acute Spinal Cord Injury
- Keywords
- Endothelin, Neurogenesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pharmazz, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.
Detailed description
Trauma is projected to be third largest killer in the developing world by 2020, with a large number of these injuries comprising of traumatic spinal cord injury. People with spinal cord injuries (SCI) are two to five times more susceptible to die than people without an injury. More than 80% cases of SCIs occur among young people between the ages of 20 and 45 years and majority of sufferers are male. In developed countries, the incidence of spinal injuries varies from 20 to 50 per million. Every year about 250,000 to 500,000 number of SCI cases are reported.
There are hidden stem cells in the brain, which becomes active following injury to the spinal cord. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the spinal cord to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic and anti-oxidant activity.
Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In PMZ group, 3 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). In control group, 3 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. In both treatment groups, subjects will be provided the best available standard of care.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Drug: Normal Saline along with standard treatmentPatients will receive the best available standard of care. In control group, 3 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. |
| PMZ-1620 | Experimental | Drug: PMZ-1620 along with standard treatmentPatients will receive the best available standard of care. In PMZ group, 3 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult males or females aged between 18 and 75 years inclusive
- Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)
- Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator)
- 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
- Willing and able to comply with the study Protocol
Key exclusion criteria (14 listed)
- Previous history related to spinal cord disease
- Patient on ventilator or requires ventilator
- Patient with pathological fracture of vertebral column
- Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified as complete injury
- One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline along with standard treatmentAlso: VehicleThe arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided. | Drug | Normal Saline |
| PMZ-1620 along with standard treatmentAlso: Sovateltide (IRL-1620) along with standard treatmentPMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. | Drug | PMZ-1620 |
Primary outcome
Incidence of PMZ-1620 related adverse events
Time frame: 90 days
The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
Number of patients not receiving full treatment
Time frame: 90 days
Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.
5 secondary outcomes
Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
Time frame: 90 days
Changes in walking index for spinal cord injury (WISCI) score
Time frame: 90 days
Changes in Spinal Cord Independence Measure (SCIM) score
Time frame: 90 days
Changes in MRI/CT
Time frame: 90 days
Changes in electromyography (EMG)
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No. Results will be communicated and published as manuscript
Related trials for Acute Spinal Cord Injury
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury
Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation
RecruitingPhase 1
NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
Recruiting
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ravi Kant contact
Anil Gulati study chair
Pharmazz, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal Saline along with standard treatment and PMZ-1620 along with standard treatment in people with Acute Spinal Cord Injury, run by Pharmazz, Inc. at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manish S Lavhale (+91 9873847397, manish.lavhale@pharmazz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PMZ-1620 related adverse events (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.