A Study of AC105 in Patients With Acute Traumatic Spinal Cord Injury
This study is enrolling participants by invitation only.
DP Clinical, Inc.
Information provided by (Responsible Party):
First received: December 13, 2012
Last updated: November 14, 2013
Last verified: November 2013
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).
|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).
|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)|
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750684
Sponsors and Collaborators
DP Clinical, Inc.
|Study Director:||Andrew Eisen, MD||Acorda Therapeutics|