Overview

PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmazz, Inc.
Criteria
Inclusion Criteria:

1. Adult males or females aged between 18 and 75 years inclusive

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

3. Able to cooperate in the completion of a standardized neurological examination by
ISNCSCI standards (excludes patients who are on ventilator)

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. 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

7. Able to receive the Investigational Drug 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

Exclusion Criteria:

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 are breastfeeding or 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. The participant has a 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 (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder
with hallucinations/delusions/schizophrenia)

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

14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this
study