ALS Study to Investigate the Safety and Efficacy of Lithium in Volunteers With ALS

 A Multicenter, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Lithium in combination with Riluzole in Volunteers with Amyotrophic Lateral Sclerosis (ALS)

Recruitment Status: Completed
 
About This Study:
To investigate lithium carbonate as a possible treatment for ALS, a randomized, double-blinded, multicenter trial of lithium carbonate with riluzole versus placebo with riluzole was conducted in people with ALS in the U.S. and Canada. The study was conducted by the Northeast ALS (NEALS) and Canadian ALS (CALS) Consortia and was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health, the ALS Association and the ALS Society of Canada.

The study used a novel “time to an event” design; an event was defined as a drop in the ALS Functional Rating Scale-Revised (ALSFRS-R) score ≥ 6 points or death. The primary analysis compared the time to an event between the lithium/riluzole and placebo/riluzole groups, as determined by the log-rank test. At the pre-specified first interim analysis, criteria for futility were met. This study did not show the same beneficial effect of lithium carbonate on the progression of ALS as the prior pilot study conducted in Italy.

The full results of the study are described in the publication Aggarwal SP, Zinman L, Simpson E, et al. Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol;9(5):481-8.

Lithium in ALS data set is available without cost to researchers and analysts; certain Conditions of Use apply. Completion of NEALS Data Request Form is required in order to receive the requested dataset. 

For more information please see the Patient Announcement from NEALS and the Canadian ALS Consortia.

Click here for a copy of the Study Protocol.