This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
551
Novartis USA
East Hanover, New Jersey, United States
Novartis Belgium
Vilvoorde, Belgium
Novartis CANADA
Dorval, Quebec, Canada
Novartis France
Rueil-Malmaison, France
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Survival time
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
Neurocognitive evaluation in a subset of patients(every visit except screening)
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Novartis Germany
Nuremberg, Germany
Novartis Italy
Saronno, Italy
Novartis Netherlands
Arnhem, Netherlands
Novartis Switzerland
Bern, Switzerland
Novartis UK
Frimley, United Kingdom