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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00072709
First Posted: November 11, 2003
Last Update Posted: November 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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)

Enrollment: 551
Study Start Date: September 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00072709     History of Changes
Other Study ID Numbers: CTCH346A2211
First Submitted: November 7, 2003
First Posted: November 11, 2003
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ALS
Lou Gehrig's disease

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases