Neurology Trial: 36 week study phase 2 study to assess the effect of drug on functional decline in subjects with ALS
INCLUSION: Male/ Female 18-75 years of age Clinically definite, laboratory probable, or clinically probable ALS ALS symptom onset < 2 years prior to screening visit Subjects on riluzole may enter the study if they have been on a stable dose of 50mg BID for >4 weeks prior to screening visit. EXCLUSION: Subject has participated in […]
Neurology Trial: 16 week study designed to assess the effect of the drug versus placebo on respiratory function with patients with ALS
INCLUSION: Male/Female 18-80 years of age Sporadic or familial ALS <24 months prior to screening SVC > 65% of predicted for age/height/sex EXCLUSION: At time of screening any use of non-invasive ventilation Neurological impairment due to a condition other than ALS Presence at screening of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness […]
Neurology Trial: 28 Week study designed to test efficacy of a fixed combination of drugs for the treatment of ALS
INCLUSION: Male/Female 18-80 years of age Sporadic or familial ALS Less than or equal to 18 months since ALS symptom onset. Slow Vital Capacity >60% of predicted value for gender/height/age at screening EXCLUSION: Presence of tracheostomy Exposure to PB/ TUDCA, or UDCA within 3 months prior to the Screening visit
