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East Hanover, New Jersey 07936


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).


Inclusion criteria: - clinical diagnosis of laboratory-supported probable, probable, or definite ALS; - sporadic or familial ALS; - ALS symptom onset for no more than 3 yrs at study entry; - FVC equal to or more than 70%; - patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start. Exclusion criteria: - Known or suspected chronic infectious disease including HIV, hepatitis B, or hepatitis C. - Clinically significant ECG abnormalities. - Known hypersensitivity to study drug or related drugs (e.g. selegiline, MAO-A and B inhibitors, or tricyclic antidepressants). - Patients treated with potent inhibitors of CYP1A2 or CYP3A4 (a list of such inhibitors will be provided to the investigator). - Treatment with MAO-A and B inhibitors (including selegiline) within the past 30 days.



Primary Contact:

Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals

Backup Contact:


Location Contact:

East Hanover, New Jersey 07936
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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