AC105 in Patients With Acute Traumatic Spinal Cord Injury

NCT ID: NCT01750684

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-05-31

Brief 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.

Detailed 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).

Conditions

Acute Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Saline

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

AC105

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.

Group Type: ACTIVE_COMPARATOR

AC105

Intervention Type: DRUG

Interventions

AC105

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

DP Clinical, Inc.

INDUSTRY

Sponsor Role: collaborator

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Eisen, MD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Other Identifiers

ACPM-SI-1009

Identifier Type: -

Identifier Source: org_study_id