Based on the strength of the pre-clinical evidence, two randomized double-blind placebo-controlled phase III trials examining the efficacy of subcutaneous rhIGF-I in the treatment of ALS have been completed[335,336]; however, the results of these two trials conflict, concluding, that more complex studies to set the potential role of IGF-I in ALS disease are required. The gene discussed is IGF1; the disease is amyotrophic lateral sclerosis.