Completed
A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis
What is being tested
Data Collection
Who is being recruted
Amyotrophic Lateral Sclerosis+8
+ Central Nervous System Diseases
+ Metabolic Diseases
From 21 to 80 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: September 2003
Summary
Principal SponsorNovartis Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.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).
Official TitleA Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis
Principal SponsorNovartis Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
551 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 21 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Amyotrophic Lateral SclerosisCentral Nervous System DiseasesMetabolic DiseasesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesProteostasis DeficienciesTDP-43 Proteinopathies
Criteria
5 inclusion criteria required to participate
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%;
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5 exclusion criteria prevent from participating
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).
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Suspended
Suspended
Novartis Belgium
Vilvoorde, BelgiumSuspended
Novartis CANADA
Dorval, CanadaSuspended
Novartis France
Rueil-Malmaison, FranceCompleted9 Study Centers