- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00230074
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
November 22, 2011 updated by: Novartis
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 Overview
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
Interventional
Enrollment (Actual)
350
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Novartis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
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Secondary Outcome Measures
Outcome Measure |
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Survival time
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Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
September 28, 2005
First Submitted That Met QC Criteria
September 28, 2005
First Posted (Estimate)
September 30, 2005
Study Record Updates
Last Update Posted (Estimate)
November 23, 2011
Last Update Submitted That Met QC Criteria
November 22, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTCH346A2211E1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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