Treatment for Acute Spinal Cord Injury using Sovateltide
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
This study is testing a new drug called sovateltide to see if it can help people with acute spinal cord injuries recover better when given soon after their injury.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pharmazz, Inc. Industry-sponsored |
| Locations | 5 sites (Belagavi and 4 other locations) |
| Trial ID | NCT04054414 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of PMZ-1620 (sovateltide) in patients with acute spinal cord injury. It is a multicentric, randomized, double-blind, parallel, saline-controlled Phase II study that compares the investigational drug with standard supportive care. The therapy aims to enhance neurogenesis and repair spinal cord damage by activating neuronal progenitor cells and promoting neurovascular repair. Participants will receive the treatment within 48 hours of injury and will be monitored for improvements in neurological function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with incomplete spinal cord injuries classified as ISNCSCI Grade B, C, or D.
Not a fit: Patients with complete spinal cord injuries or those on ventilators may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with acute spinal cord injuries.
How similar studies have performed: While there have been studies on neurogenesis and spinal cord injury treatments, the specific approach using sovateltide is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belagavi and 4 other locations
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre — Belagavi, India (Not_yet_recruiting)
- Institute of Postgraduate Medical Education & Research and SSKM Hospital — Kolkata, India (Recruiting)
- King George's Medical University — Lucknow, India (Recruiting)
- Rahate Surgical Hospital & ICU — Nagpur, India (Recruiting)
- Indian Spinal Injury Centre — New Delhi, India (Recruiting)
Study contacts
- Study coordinator: Manish S Lavhale
- Email: manish.lavhale@pharmazz.com
- Phone: +91 9873847397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.