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

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Tch 346

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Novartis:

ALS
Lou Gehrig's disease

Additional relevant MeSH terms:

Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases

Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on November 09, 2009