A Study of AC105 in Patients With Acute Traumatic Spinal Cord Injury (AC105)
|ClinicalTrials.gov Identifier: NCT01750684|
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : June 13, 2016
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Spinal Cord Injury||Drug: AC105 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||July 2013|
|Primary Completion Date :||February 2015|
|Study Completion Date :||May 2015|
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.
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: up to 6 months ]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.
- 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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750684
|Study Director:||Andrew Eisen, MD||Acorda Therapeutics|