Clinical trial NCT01750684: AC105 in Patients With Acute Traumatic Spinal Cord Injury
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Spinal Cord Injury
Keywords: Acute
Traumatic
SCI
Spinal Cord Injury
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: DP Clinical, Inc.
First posted: 2012-12-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: up to 6 months
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data
timeFrame: baseline, prior to and up to 5 hours following last infusion
Other outcomes:
Locations:
Study officials:
affiliation: Acorda Therapeutics
name: Andrew Eisen, MD
role: STUDY_DIRECTOR
References: