A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00230074

First received: September 28, 2005

Last updated: November 22, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 28, 2005
Last Updated Date	November 22, 2011
Start Date ^ICMJE	November 2004
Primary Completion Date	February 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00230074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Survival time Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Official Title ^ICMJE	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 Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Amyotrophic Lateral Sclerosis
Intervention ^ICMJE	Drug: TCH346
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	350
Completion Date	February 2005
Primary Completion Date	February 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Completed original protocol, Study No. CTCH346A2211 Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained Exclusion Criteria: Exclusion criteria as described in the original protocol will remain applicable into the extension protocol Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	21 Years to 80 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 Number ^ICMJE	NCT00230074
Other Study ID Numbers ^ICMJE	CTCH346A2211E1
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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