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
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
Treatments tested in this trial
- Normal Saline along with standard treatment
- PMZ-1620 along with standard treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov