A Study of AC105 in Patients With Acute Traumatic Spinal Cord Injury



Status:Completed
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2013
End Date:June 2015

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A Phase 2 Double-blind, Randomized, Placebo-controlled Study to Determine the Safety, Tolerability and Potential Activity of AC105 Following a Regimen of 6 Doses Over 30 Hours in Patients With Acute Traumatic Spinal Cord Injury (SCI) as Compared to Patients Treated With Placebo.


To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses
over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).


Inclusion Criteria:

- Male or female between 18 and 65 years of age, inclusive

- Acute traumatic SCI, at a neurological level between C4 and T11

- No evidence of penetrating or transection injury (e.g. caused by projectile or stab
wound)

- Neurological ASIA Impairment Scale A, B or C

- Able to provide written or verbal witnessed consent

- Able to initiate treatment within 12 hours of injury

Exclusion Criteria:

- Known allergy or hypersensitivity to polyethylene glycol

- Mental impairment or other conditions that would preclude a reliable ASIA exam or
adequate consent

- Positive pregnancy test result

- Serum creatinine level ≥2 mg/dL

- History or active renal failure or dialysis

- Mean arterial blood pressure < 60 mmHg despite vasopressor treatment

- On a current regimen of digoxin

- Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or
the use of magnesium salts in the acute care setting prior to the administration of
investigational product

- Any other medical condition that, in the judgment of the investigator, would preclude
provision of informed consent, make participation in the study unsafe, or
unreasonably complicate follow-up or the interpretation of study outcome data or may
otherwise interfere with achieving the study objectives

- In the judgment of the Investigator, cannot adequately provide informed consent, is
likely to be non-compliant, or may be unable to cooperate with study requirements
We found this trial at
2
sites
636
mi
from
Milwaukee, WI
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
1358
mi
from
Stony Brook, NY
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