AC105 in Patients With Acute Traumatic Spinal Cord Injury

NCT01750684 | Terminated Phase 2 Results DMC

• 1 other identifier: ACPM-SI-1009
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Spinal Cord Injury

Keywords

Acute; Traumatic; SCI; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 months

Secondary Outcomes (1)

• Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data

  baseline, prior to and up to 5 hours following last infusion

Study Arms (2)

Saline

PLACEBO COMPARATOR

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

AC105

ACTIVE COMPARATOR

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

Interventions

AC105 DRUG

AC105

Placebo OTHER

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorda Therapeutics: lead
• United States Department of Defense: collaborator
• DP Clinical, Inc.: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Acorda Therapeutics, Inc.

acorda@acorda.com

914-347-4300

Study Officials

• Andrew Eisen, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: July 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 6, 2018
• Results First Posted: June 13, 2016

Record last verified: 2018-10