Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
Phase 2
Completed
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT00072709
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (9)
Novartis USA
๐บ๐ธEast Hanover, New Jersey, United States
Novartis Belgium
๐ง๐ชVilvoorde, Belgium
Novartis Switzerland
๐จ๐ญBern, Switzerland
Novartis Netherlands
๐ณ๐ฑArnhem, Netherlands
Novartis Italy
๐ฎ๐นSaronno, Italy
Novartis France
๐ซ๐ทRueil-Malmaison, France
Novartis UK
๐ฌ๐งFrimley, United Kingdom
Novartis Germany
๐ฉ๐ชNuernberg, Germany
Novartis CANADA
๐จ๐ฆDorval, Quebec, Canada