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A 12-week, multicenter, safety and dose-ranging study of 3 oral doses of TCH346 in patients with Amyotrophic Lateral Sclerosis

This study is no longer recruiting patients.

Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals

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 Treatment or Intervention Phase
Amyotrophic Lateral Sclerosis
 Drug: TCH346
Phase II

MedlinePlus related topics:  Amyotrophic Lateral Sclerosis
Genetics Home Reference related topics:  amyotrophic lateral sclerosis

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

Further Study Details: 

Expected Total Enrollment:  48

Study start: January 2002;  Study completion: August 2002

Eligibility

Ages Eligible for Study:  40 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria


Location Information


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

Canada, Quebec
      Novartis CANADA, Dorval,  Quebec,  Canada

More Information

Study ID Numbers:  CTCH346 0102
Record last reviewed:  July 2003
Record first received:  May 9, 2002
ClinicalTrials.gov Identifier:  NCT00036413
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29
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