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
Data Collection
Amyotrophic Lateral Sclerosis+9
+ Central Nervous System Diseases
+ Metabolic Diseases
Treatment Study
Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.551 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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
Novartis Belgium
Vilvoorde, BelgiumNovartis CANADA
Dorval, CanadaNovartis France
Rueil-Malmaison, France