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Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS) Clinical research trials and Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS) health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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) Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS) clinical trial. Human subjects often get the best healthcare possible for their Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > 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)
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
Other Amyotrophic Lateral Sclerosis Studies:
1. A 12-week, multicenter, safety and dose-ranging study of 3 oral doses of TCH346 in patients with Amyotrophic Lateral Sclerosis
2. Determinants of Disease Severity in Amyotrophic Lateral Sclerosis
3. Creatine for the Treatment of Amyotrophic Lateral Sclerosis
4. Nuclear Magnetic Spectroscopy Imaging to Evaluate Primary Lateral Sclerosis, Hereditary Spastic Paraplegia and Amyotrophic Lateral Sclerosis
5. Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
Related Studies:
Other Amyotrophic Lateral Sclerosis Clinical Trials
Other New Jersey Clinical Trials
Other East Hanover Clinical Trials
Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS)
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