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

Launched by PHARMAZZ, INC. · Aug 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PMZ-1620 (also known as Sovateltide) for patients who have suffered an acute spinal cord injury. The trial aims to determine if this treatment, when given alongside standard care, is safe and effective for improving recovery. It is being conducted at multiple centers and is currently looking for participants aged 18 to 75 who have certain types of incomplete spinal cord injuries and can undergo a specific neurological examination.

To be eligible, participants must be able to consent to the study and receive the treatment within 48 hours of their injury. They should not have a complete spinal cord injury or other serious medical conditions that could affect their participation. Those who join the trial can expect to receive either the investigational drug or a saline solution (a saltwater solution) without knowing which one they are getting, as the study is designed to be double-blind. This means that both the participants and the researchers do not know who is receiving the treatment or the placebo, which helps ensure fair results. Overall, this study hopes to find new ways to help people recover from spinal cord injuries.

Gender

ALL

Eligibility 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