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AC105 in Patients With Acute Traumatic Spinal Cord Injury (AC105)

Primary Purpose

Acute Spinal Cord Injury

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AC105
Placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury focused on measuring Acute, Traumatic, SCI, Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Saline

    AC105

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
    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
    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).

    Full Information

    First Posted
    December 13, 2012
    Last Updated
    October 9, 2018
    Sponsor
    Acorda Therapeutics
    Collaborators
    United States Department of Defense, DP Clinical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01750684
    Brief Title
    AC105 in Patients With Acute Traumatic Spinal Cord Injury
    Acronym
    AC105
    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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    The study was terminated by the Sponsor due to insufficient enrollment.
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Acorda Therapeutics
    Collaborators
    United States Department of Defense, DP Clinical, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Spinal Cord Injury
    Keywords
    Acute, Traumatic, SCI, Spinal Cord Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm 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.
    Arm Title
    AC105
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    AC105
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
    Description
    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.
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data
    Description
    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).
    Time Frame
    baseline, prior to and up to 5 hours following last infusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Eisen, MD
    Organizational Affiliation
    Acorda Therapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    AC105 in Patients With Acute Traumatic Spinal Cord Injury

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