AC105 in Patients With Acute Traumatic Spinal Cord Injury

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Collaborators: DP Clinical, Inc.; United States Department of Defense

Criteria

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

• Patient is able to provide written or verbal witnessed consent. If unable to provide either, consent may be provided by legally authorized representative (LAR)

• Patient is able to initiate treatment within time window 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 urine 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