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

Recruiting now · Phase 2

Conditions studied: Acute Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT04054414

Run by

Pharmazz, Inc.

People needed

40

Starts

2019-01-10

Expected to finish

2026-07-01

Last updated by the study team

2025-07-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute of Postgraduate Medical Education & Research and SSKM Hospital — Kolkata, India (enrolling)
• King George's Medical University — Lucknow, India (enrolling)
• Rahate Surgical Hospital & ICU — Nagpur, India (enrolling)
• Indian Spinal Injury Centre — New Delhi, India (enrolling)
• KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre — Belagavi, India

Full record on ClinicalTrials.gov

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