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Trial record 1 of 1 for:    01750684
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A Study of AC105 in Patients With Acute Traumatic Spinal Cord Injury (AC105)

This study has been completed.
United States Department of Defense
DP Clinical, Inc.
Information provided by (Responsible Party):
Acorda Therapeutics Identifier:
First received: December 13, 2012
Last updated: May 6, 2016
Last verified: May 2016
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).

Condition Intervention Phase
Acute Spinal Cord Injury
Drug: AC105
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Safety and Tolerability Assessed by Comparing Adverse Event (AE) Data for Patients Administered a Regimen of 6 Intravenous Doses of AC105 Over 30 Hours Compared With Patients Administered the Same Regimen of Placebo. [ Time Frame: up to 6 months ]
    Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion.

Secondary Outcome Measures:
  • Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data [ Time Frame: baseline, prior to and up to 5 hours following last infusion ]
    Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC).

Enrollment: 15
Study Start Date: July 2013
Study Completion Date: May 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Other: Placebo
Active Comparator: 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.
Drug: AC105


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01750684

Sponsors and Collaborators
Acorda Therapeutics
United States Department of Defense
DP Clinical, Inc.
Study Director: Andrew Eisen, MD Acorda Therapeutics
  More Information

Responsible Party: Acorda Therapeutics Identifier: NCT01750684     History of Changes
Other Study ID Numbers: ACPM-SI-1009
Study First Received: December 13, 2012
Results First Received: May 6, 2016
Last Updated: May 6, 2016

Keywords provided by Acorda Therapeutics:
Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System processed this record on April 26, 2017