- ALS drug development: reflections from the past and a way forwardSwati Aggarwal
Department of Neurology, Massachusetts General Hospital, Neurology Clinical Trials Unit, Charlestown, Massachusetts 02129, USA
Neurotherapeutics 5:516-27. 2008..We present a critical overview of past clinical trials, how therapies are selected for testing in people, challenges with ALS clinical trial design and conduct, and ways to best move forward...
- Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trialSwati P Aggarwal
Neurology Clinical Trials Unit, Massachusetts General Hospital, Charlestown, MA, USA
Lancet Neurol 9:481-8. 2010..In a pilot study, lithium treatment slowed progression of amyotrophic lateral sclerosis (ALS). We aimed to confirm or disprove these findings by assessing the safety and efficacy of lithium in combination with riluzole in patients with ALS...
- Toward more efficient clinical trials for amyotrophic lateral sclerosisMerit E Cudkowicz
Massachusetts General Hospital, Boston, Massachusetts, USA
Amyotroph Lateral Scler 11:259-65. 2010..Here we summarize our current thinking about phase II design options and the potential benefits of a clinical trial network for phase II trials in ALS...