The phase III trial of Ceftriaxone; Neuraltus, the Phase II study of NP001 in ALS; and EMPOWER, the Phase III study of Dexpramipexole in ALS, are no longer recruiting participants.
Ceftriaxone, NP001, and Dexpramipexole Trials Close Enrollment
Enrollment has closed on three multi-center ALS clinical trials.
The National Institute of Neurological Disorders and Stroke (NINDS) is supporting a phase III clinical trial to determine the efficacy and long term safety of ceftriaxone in ALS. Ceftriaxone has anti-glutamate and anti-inflammatory properties that are protective for motor neurons. Several ALS scientists have reported that ceftriaxone protects cells from injury in in vitro and in vivo models of motor neuron disease. Screening for the Ceftriaxone trial was completed on November 11, 2011. Results are expected by the end of 2012.
The NP001 trial, sponsored by Neuraltus Pharmaceuticals, is a randomized, double-blind, placebo-controlled Phase II trial examining the effects of NP001, administered intravenously, on clinical function at two dose levels. NP001 has anti-inflammatory properties. The trial enrolled 105 people at multiple centers.
The NEALS-affiliated dexpramipexole trial, named EMPOWER and sponsored by Biogen Idec (Cambridge, Mass), is a randomized, double-blind, placebo-controlled Phase III study investigating the safety and efficacy of dexpramipexole as a potential treatment for ALS. The study is fully enrolled at multiple clinical sites throughout the United States, Canada, Europe, and Australia. Results of the EMPOWER study are expected in late 2012. Dexpramipexole is an orally administered drug shown to have neuroprotective properties in preclinical models. In a Phase II study of dexpramipexole in 102 ALS subjects (Study KNS-760704-CL201), sponsored by Knopp Biosciences (Pittsburgh, PA) and led by NEALS, dose-dependent slowing of functional decline and a trend towards improved survival were found.