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Glyburide Opportunity for Spinal Cord Injury Protection

2015-08-16 19:35:16 | BioPortfolio

Summary

The purpose of this study is to determine the safety of using intravenous Glyburide (RP-1127) in patients with acute traumatic cervical spinal cord injuries (SCI).

Description

This study will include patients between 18 and 70 years who have experienced acute traumatic cervical spinal cord injury (specifically ASIA A, B or C). Patients will then begin an infusion of RP-1127 (Glyburide), which must be started within 6 hours of injury and continued for 72 hours at a daily dose of 2.99 mg on Day 1, 2.67 mg on Day 2 and 2.67 mg on Day 3. If indicated, the patient will also have surgical intervention for spinal cord decompression and spinal stabilization. Every one who takes part in this study will have labs drawn and adverse events assessed through Day 14 or discharge (whichever is earlier), and be carefully monitored throughout their hospitalization. Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow up occuring on Days 28, 42, 84, 182 and 365.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Spinal Cord Injuries

Intervention

RP-1127

Location

University of Louisville
Louisville
Kentucky
United States
40202

Status

Not yet recruiting

Source

Ohio State University

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-08-16T19:35:16-0400

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Medical and Biotech [MESH] Definitions

Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.

Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.).

A syndrome associated with damage to the spinal cord above the mid thoracic level (see SPINAL CORD INJURIES) characterized by a marked increase in the sympathetic response to minor stimuli such as bladder or rectal distention. Manifestations include HYPERTENSION; TACHYCARDIA (or reflex bradycardia); FEVER; FLUSHING; and HYPERHIDROSIS. Extreme hypertension may be associated with a STROKE. (From Adams et al., Principles of Neurology, 6th ed, pp538 and 1232; J Spinal Cord Med 1997;20(3):355-60)

Longitudinal cavities in the spinal cord, most often in the cervical region, which may extend for multiple spinal levels. The cavities are lined by dense, gliogenous tissue and may be associated with SPINAL CORD NEOPLASMS; spinal cord traumatic injuries; and vascular malformations. Syringomyelia is marked clinically by pain and PARESTHESIA, muscular atrophy of the hands, and analgesia with thermoanesthesia of the hands and arms, but with the tactile sense preserved (sensory dissociation). Lower extremity spasticity and incontinence may also develop. (From Adams et al., Principles of Neurology, 6th ed, p1269)

Reduced blood flow to the spinal cord which is supplied by the anterior spinal artery and the paired posterior spinal arteries. This condition may be associated with ARTERIOSCLEROSIS, trauma, emboli, diseases of the aorta, and other disorders. Prolonged ischemia may lead to INFARCTION of spinal cord tissue.

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