Health TrialsbyHealthPanel

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

ConditionAcute Spinal Cord Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPharmazz, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Normal Saline along with standard treatment

    Drug

    The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.

  • PMZ-1620 along with standard treatment

    Drug

    PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Normal SalineActive comparator 1 intervention
Group B: PMZ-1620Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of PMZ-1620 related adverse events

The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.

Time frame
90 days
2

Number of patients not receiving full treatment

Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.

Time frame
90 days

Secondary outcomes

1

Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI)

Statistically relevant changes in clinical progression of ASCI as measured by ISNCSCI scoring at one, two and three months after treatment. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) or more commonly referred to as the ASIA Impairment Scale (AIS), is a universal classification tool for Spinal Cord Injury based on a standardized sensory and motor assessment. Ranges from A to E where A = Complete and no sensory or motor function is preserved and E = Normal sensory and motor functions

Time frame
90 days
2

Changes in walking index for spinal cord injury (WISCI) score

Statistically relevant changes in WISCI Score at one, two and three months after treatment. This test assesses the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It rank orders the ability of a person to walk 10 meter after a spinal cord injury from most to least severe impairment. A score from 0 to 20 is assigned, level 0: patient is unable to stand and/or participate in walking and level 20 patient ambulates with no devices, with brace and no assistance.

Time frame
90 days
3

Changes in Spinal Cord Independence Measure (SCIM) score

Statistically relevant changes in SCIM score at one, two and three months after treatment. Spinal Cord Independence Measure (SCIM) scale is used to measure the disability to specifically address the ability of SCI patients to perform basic activities of daily living independently. The SCIM scores range from 0 to 100 where where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.

Time frame
90 days
4

Changes in MRI/CT

Changes in MRI/CT, before (baseline) and three months after treatment. Radiological evidence of transaction of spinal cord will be recorded by CT or MRI scan. In addition, edema, contusion, extent of spinal cord damage will be recorded.

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmazz, Inc.

Lead sponsor

Source ClinicalTrials.gov
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