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Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS)



Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS)

For Condition: Amyotrophic Lateral Sclerosis
Status: No longer recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: 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).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/80 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 500

Location and Contact Information:

Novartis Netherlands
ARNHEM,  , 
Netherlands
 

Novartis France
Rueil-Malmaison,  , 
France
 

Novartis USA
East Hanover,  New Jersey,  07936
United States
 

Novartis Belgium
Vilvoorde,  , 
Belgium
 

Novartis Germany
Nuernberg,  , 
Germany
 

Novartis Italy
Saronno,  , 
Italy
 

Novartis UK
Frimley,  , 
United Kingdom
 

Novartis Switzerland
Bern,  , 
Switzerland
 

Novartis CANADA
Dorval,  Quebec, 
Canada
 


Additional Information:
Study ID Numbers:
  CTCH346A2211; 
Study Start Date: September 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072709

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