Actively Recruiting
PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
Led by Pharmazz, Inc. · Updated on 2025-07-04
40
Participants Needed
5
Research Sites
389 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 75 years
- Able to provide consent personally or through a legal representative
- Able to cooperate with standardized neurological examination by ISNCSCI standards
- ISNCSCI Impairment Scale Grade B, C, or D indicating motor or sensory incomplete injury
- Willing and able to follow study protocol
- Women must be non-childbearing, surgically sterile, or willing to use birth control; sexually active men must also use birth control
- Able to receive the study drug within 48 hours of injury
- Neurological injury level between C5-C8, T1-T12, L1-L5, or S1-S5
- Partial spinal cord damage confirmed by CT or MRI scan
- Stable chronic conditions with appropriate treatment
You will not qualify if you...
- History of spinal cord disease
- Currently on or requiring a ventilator
- Pathological fracture of vertebral column
- ISNCSCI Impairment Scale Grade A indicating complete injury
- One or more upper extremity muscle groups untestable during baseline neurological exam
- Significant head injury with abnormal head CT
- Female who is breastfeeding or has a positive pregnancy test
- Body mass index (BMI) of 35 kg/m2 or higher
- Known immunodeficiency or using immunosuppressive or cancer chemotherapy drugs
- Diagnosis of rheumatoid arthritis
- Clinically significant cardiovascular disorder or abnormal ECG
- Pre-existing neurological disorders preventing accurate evaluation (e.g., Alzheimer's, Parkinson's, psychiatric disorders with hallucinations or delusions)
- Currently participating in another clinical trial with investigational drug or device
- Any other condition that makes the participant unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, India, 590010
Not Yet Recruiting
2
Institute of Postgraduate Medical Education & Research and SSKM Hospital
Kolkata, India, 700020
Actively Recruiting
3
King George's Medical University
Lucknow, India, 226018
Actively Recruiting
4
Rahate Surgical Hospital & ICU
Nagpur, India, 440008
Actively Recruiting
5
Indian Spinal Injury Centre
New Delhi, India, 110070
Actively Recruiting
Research Team
M
Manish S Lavhale
CONTACT
R
Ravi Kant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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