PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
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| ClinicalTrials.gov Identifier: NCT04054414 |
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Recruitment Status :
Recruiting
First Posted : August 13, 2019
Last Update Posted : August 23, 2022
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Sponsor:
Pharmazz, Inc.
Information provided by (Responsible Party):
Pharmazz, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Spinal Cord Injury | Drug: Normal Saline along with standard treatment Drug: PMZ-1620 along with standard treatment | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 10, 2019 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | July 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Spinal Cord Injuries
Drug Information available for:
Sodium chloride
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Normal Saline
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.
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Drug: Normal Saline along with standard treatment
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.
Other Name: Vehicle |
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Experimental: PMZ-1620
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).
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Drug: PMZ-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.
Other Name: Sovateltide (IRL-1620) along with standard treatment |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI) [ Time Frame: 90 days ]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
- Changes in walking index for spinal cord injury (WISCI) score [ Time Frame: 90 days ]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.
- Changes in Spinal Cord Independence Measure (SCIM) score [ Time Frame: 90 days ]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.
- Changes in MRI/CT [ Time Frame: 90 days ]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.
- Changes in electromyography (EMG) [ Time Frame: 90 days ]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.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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)
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054414
Contacts
| Contact: Manish S Lavhale | +91 9873847397 | manish.lavhale@pharmazz.com | |
| Contact: Ravi Kant | ravi.kant@pharmazz.com |
Locations
| India | |
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre | Not yet recruiting |
| Belgaum, India, 590010 | |
| Contact: Sameer Haveri +91 9844333082 drsameerhaveri@gmail.com | |
| Institute of Postgraduate Medical Education & Research and SSKM Hospital | Recruiting |
| Kolkata, India, 700020 | |
| Contact: Rajat Choudhuri +91 9874660960 rajat.choudhuri@gmail.com | |
| King George's Medical University | Recruiting |
| Lucknow, India, 226018 | |
| Contact: Shah Waliullah +91-9335716350 shahwali2008@gmail.com | |
| Rahate Surgical Hospital & ICU | Recruiting |
| Nagpur, India, 440008 | |
| Contact: Ravi P Dashputra +91-9823079739 ravidash123@gmail.com | |
| Indian Spinal Injury Centre | Recruiting |
| New Delhi, India, 110070 | |
| Contact: H.S. Chhabra +91 11 42255356 drhschhabra@isiconline.org | |
Sponsors and Collaborators
Pharmazz, Inc.
Investigators
| Study Chair: | Anil Gulati | Pharmazz, Inc. |
| Responsible Party: | Pharmazz, Inc. |
| ClinicalTrials.gov Identifier: | NCT04054414 |
| Other Study ID Numbers: |
PMZ-1620/CLINICAL-2.3/2017 CTRI/2018/12/016667 ( Registry Identifier: Clinical Trials Registry - India ) |
| First Posted: | August 13, 2019 Key Record Dates |
| Last Update Posted: | August 23, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Results will be communicated and published as manuscript |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pharmazz, Inc.:
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Endothelin Neurogenesis |
Additional relevant MeSH terms:
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Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |