Status:
RECRUITING
PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
Lead Sponsor:
Pharmazz, Inc.
Conditions:
Acute Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04054414
Start Date
January 10 2019
End Date
July 1 2026
Last Update
July 4 2025
Active Locations (5)
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1
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, India, 590010
2
Institute of Postgraduate Medical Education & Research and SSKM Hospital
Kolkata, India, 700020
3
King George's Medical University
Lucknow, India, 226018
4
Rahate Surgical Hospital & ICU
Nagpur, India, 440008