Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036413
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2002-05-09
Brief Title:
A 12-week Multicenter Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 12-week Randomized Double-blind Placebo-controlled Parallel Group Multicenter Safety and Dose-ranging Study of Three Oral Doses 05 mg 25 mg and 10 mg Once Daily of TCH346 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 study is the first to be performed in Amyotrophic Lateral Sclerosis ALS patients with the novel compound TCH346 Its purpose is to evaluate the safety and clinical effects of 3 dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of laboratory-supported probable probable or definite ALS The study will require patients to visit the study center a total of at least 7 times over the course of up to 14 weeks The study consists of 2 phases A screening phase up to 2 weeks when patients will be evaluated for eligibility to participate in the study and a double-blind treatment phase 12 weeks when patients will receive daily doses of either TCH346 or placebo and will be evaluated for clinical effects In addition patients eligible to participate in this study will be required to have 3 magnetic resonance spectroscopic MRS scans The MRS is a non-invasive painless brain scan The MRS will require traveling to a designated center in Montreal Canada which is very experienced in performing such MRS scans in ALS patients
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