Clinical Trial: A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Brief Summary: This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.
Detailed Summary: This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.
Sponsor: Novartis
Current Primary Outcome: Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Original Primary Outcome:
Current Secondary Outcome:
- Survival time
- Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 28, 2005
Date Started: November 2004
Date Completion:
Last Updated: November 22, 2011
Last Verified: November 2011
