PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
Recruiting
Phase 2Interventional Study
Acute Spinal Cord Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Pharmazz, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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
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