A 12-Week, Multicenter, Safety and Dose-Ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis - Tabular View

Tracking Information
First Received Date ^ICMJE	May 9, 2002
Last Updated Date	November 29, 2007
Start Date ^ICMJE	January 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 24, 2006)	Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00036413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 24, 2006)	Biomarker assessments at week 12
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A 12-Week, Multicenter, Safety and Dose-Ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis
Official Title ^ICMJE
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Condition ^ICMJE	Amyotrophic Lateral Sclerosis
Intervention ^ICMJE	Drug: TCH346
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	October 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	clinical diagnosis of laboratory-supported probable, probable, or definite ALS; have sporadic or familial ALS; have shown ALS symptom onset for no more than 3 yrs., inclusive, prior to randomization; FVC of >60%; ability to tolerate MRS evaluation
Gender	Both
Ages	40 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00036413
Responsible Party
Study ID Numbers ^ICMJE	CTCH346 0102
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP