Reply to Bedlack et al.: A small pilot study calls for large clinical trials to evaluate the effects of lithium before prescribing the drug for amyotrophic lateral sclerosis
- Francesco Fornai*,†,‡,
- Gabriele Siciliano§,
- Maria Laura Manca§,
- Luigi Murri§,
- Antonio Paparelli*, and
- Stefano Ruggieri‡
- *Department of Human Morphology and Applied Biology and
- §Department of Neuroscience, Clinical Neurology, University of Pisa, 56100 Pisa, Italy; and
- †Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed, 86077 Pozzilli (IS), Italy
In response to the letter from Bedlack et al. (1), our small clinical study (2) represents a preliminary screening for potential neuroprotective effects of lithium in ALS, in line with the need for small studies to select new drugs to be tested in large clinical trials (3). This pilot study was based at Istituto Neurologico Mediterraneo, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed in Pozzilli (IS), Italy (protocol deposited on June 14, 2005; registered by the Trials Office on June 21, 2005; approved by the Ethical Committee on July 26, 2005). At the time of publication, we were not aware of the potential to register such studies internationally, a procedure we fully endorse and are using for the multicenter follow-up.
Forty-four patients were selected …
‡To whom correspondence may be addressed. E-mail: f.fornai{at}med.unipi.it
