PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
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
Pharmazz, Inc.
40 participants
Jan 10, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 Criteria14
- 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
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Interventions
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 (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.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04054414