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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
DP Clinical, Inc.
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01750684
First received: December 13, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    All adverse events reported by the patient or observed by the study personnel from the time informed consent is obtained and up to the patient's study completion or discontinuation will be recorded on the Adverse Event Case Report Form.


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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750684

Sponsors and Collaborators
Acorda Therapeutics
DP Clinical, Inc.
Investigators
Study Director: Andrew Eisen, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01750684     History of Changes
Other Study ID Numbers: ACPM-SI-1009
Study First Received: December 13, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Acorda Therapeutics:
Acute
Traumatic
SCI
Spinal Cord Injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014