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

This study has been completed.

Sponsored by: 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

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 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 November 20, 2008




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