AC105 in Patients With Acute Traumatic Spinal Cord Injury

Acorda Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Acute Spinal Cord Injury

Treatments: Drug: AC105; Other: Placebo

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01750684

ACPM-SI-1009

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

15 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.

Treatment:

Other: Placebo

AC105

Active Comparator group

Description:

Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.

Treatment:

Drug: AC105