A 12-Week, Multicenter, Safety and Dose-Ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00036413

Purpose

This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3 dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of laboratory-supported probable, probable or definite ALS. The study will require patients to visit the study center a total of at least 7 times over the course of up to 14 weeks. The study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated for eligibility to participate in the study, and a double-blind treatment phase (12 weeks) when patients will receive daily doses of either TCH346 or placebo and will be evaluated for clinical effects. In addition, patients eligible to participate in this study will be required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive, painless, "brain scan". The MRS will require traveling to a designated center in Montreal, Canada, which is very experienced in performing such MRS scans in ALS patients.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: TCH346	Phase II

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

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:

Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS

Secondary Outcome Measures:

Biomarker assessments at week 12

Estimated Enrollment:	48
Study Start Date:	January 2002
Study Completion Date:	October 2002

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
have sporadic or familial ALS;
have shown ALS symptom onset for no more than 3 yrs., inclusive, prior to randomization;
FVC of >60%;
ability to tolerate MRS evaluation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036413

Locations

United States, New York
Neurological Institute
New York, New York, United States, 10032

Sponsors and Collaborators

Novartis

More Information

No publications provided

Study ID Numbers:	CTCH346 0102
Study First Received:	May 9, 2002
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00036413 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

(ALS)

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 27, 2009