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Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS) | Clinical Trials | Clareo Health

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Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)

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

NCT00072709•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

Novartis USA

East Hanover, New Jersey, United States

Novartis Belgium

Vilvoorde, Belgium

Novartis CANADA

Dorval, Quebec, Canada

Novartis France

Rueil-Malmaison, France

Novartis Germany

Nuremberg, Germany

Novartis Italy

Saronno, Italy

Novartis Netherlands

Arnhem, Netherlands

Novartis Switzerland

Bern, Switzerland

Novartis UK

Frimley, United Kingdom

Key Dates

Start Date

September 1, 2003

Primary Completion Date

December 1, 2004

Completion Date

December 1, 2004

Last Updated

November 24, 2011

Enrollment

551

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

TCH346

DRUG

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

View study

RECRUITING

Intermuscular Coherence as a Biomarker for ALS

NCT05104710

Amyotrophic Lateral Sclerosis

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RECRUITING

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

UPenn Observational Research Repository on Neurodegenerative Disease

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

Control Cohort CTRL COH

ASSESS ALL ALS Study