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 |
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
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