Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria: patients aged 25 and 80 years female patients who are either postmenopausal for at least 24 month or who are willing and able to practice the methods of contraception following the Pharmion-Risk Managment Program (PRMP) Male patients who are willing and able to practice the methods of contraception along with their female partners of childbearing potential following the PRMP Clinical diagnosis of probable and definite ALS Sporadic or familial ALS Onset of pareses for no more than 4 years Vital capacity equal to or more than 65% of the predicted value Treatment with riluzole 100mg/day Patients who are willing to give informed consent Exclusion Criteria: pregnancy or breast feeding female patients who are unwilling or unable to practice the methods of contraception following the Pharmion-Risk Managment Program (PRMP) Male patients who are willing and able to practice the methods of contraception along with their female partners of childbearing potential following the PRMP Patients unlikely to comply with the PRMP and other study requirements Patients with significant sensory abnormalities, dementia, uncompensated medical illnesses and psychiatric disorders Laboratory abnormalities consistent with clinically significant cardiovascular, respiratory, haematological, metabolic, hepatic and renal disease Infectious disease including HIV, hepatitis B and C monoclonal gammopathy of unknown significance (MGUS) History of substance abuse within the past year History of recurrent thrombosis Continuous non-invasive ventilation (ventilation-free interval equal to or less than 2 hours daily) Tracheotomy and invasive ventilation Treatment with investigational drug within 3 months prior to screening patients with clinically signifikant sensory polyneuropathy (inflammatory neuropathy cause and treatment sensory sum score - ISS ≥ 2) patients with sleep disorder (Epworth Sleeping Scale-ESS ≥ 10)