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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
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
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

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
NCT00072709
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

Novartis USA

East Hanover, United StatesOpen Novartis USA in Google Maps
Suspended

Novartis Belgium

Vilvoorde, Belgium
Suspended

Novartis CANADA

Dorval, Canada
Suspended

Novartis France

Rueil-Malmaison, France
Completed9 Study Centers