Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072709
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2003-11-07
Brief Title:
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis ALS
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Stratified Parallel-Group Multicenter Dose-Ranging Study Evaluating Four Oral Doses of TCH346 10 25 75 and 15 mg Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 10 25 75 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None