A Long-Term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

This study has been completed.

First Received: September 28, 2005 Last Updated: November 29, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00230074

Purpose

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: TCH346	Phase II

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: 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 Long-Term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

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)

Estimated Enrollment:	500
Study Start Date:	November 2004
Study Completion Date:	February 2005

Detailed Description:

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Eligibility

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

Criteria

Inclusion Criteria:

Completed original protocol, Study No. CTCH346A2211
Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained

Exclusion Criteria:

Exclusion criteria as described in the original protocol will remain applicable into the extension protocol

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230074

Locations

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

Sponsors and Collaborators

Novartis

More Information

No publications provided

Study ID Numbers:	CTCH346A2211E1
Study First Received:	September 28, 2005
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00230074 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Amyotrophic Lateral Sclerosis; ALS

Study placed in the following topic categories:

Lou Gehrig's Disease
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases

Sclerosis
Neurodegenerative Diseases
Degenerative Motor System Disease
Motor Neuron 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 May 07, 2009