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

Purpose

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).

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: TCH346	Phase II

Genetics Home Reference related topics:

amyotrophic lateral sclerosis

MedlinePlus related topics:

Amyotrophic Lateral Sclerosis

ChemIDplus related topics:

Tch 346

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Rate of functional decline as defined by the ALS Functional Rating Scale-Revised

Secondary Outcome Measures:

Survival time
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
Neurocognitive evaluation in a subset of patients(every visit except screening)

Estimated Enrollment:	500
Study Start Date:	September 2003
Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072709

Locations


United States, New Jersey
	Novartis USA
	East Hanover, New Jersey, United States, 07936

Belgium
	Novartis Belgium
	Vilvoorde, Belgium

Canada, Quebec
	Novartis CANADA
	Dorval, Quebec, Canada

France
	Novartis France
	Rueil-Malmaison, France

Germany
	Novartis Germany
	Nuernberg, Germany

Italy
	Novartis Italy
	Saronno, Italy

Netherlands
	Novartis Netherlands
	Arnhem, Netherlands

Switzerland
	Novartis Switzerland
	Bern, Switzerland

United Kingdom
	Novartis UK
	Frimley, United Kingdom

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CTCH346A2211
First Received:	November 7, 2003
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00072709
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

ALS

Lou Gehrig's disease

Study placed in the following topic categories:

Amyotrophic lateral sclerosis

Neuromuscular Diseases

Spinal Cord Diseases

Amyotrophic Lateral Sclerosis

Central Nervous System Diseases

Lou Gehrig's disease

Sclerosis

Degenerative motor system disease

Neurodegenerative Diseases

Motor neuron disease

Motor Neuron Disease

Additional relevant MeSH terms:

Pathologic Processes

Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00072709