Back to resultsA Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TCH346
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis; ALS
Eligibility Criteria
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.
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary Outcome Measures
Survival time
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00230074
Brief Title
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Official Title
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis; ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TCH346
Primary Outcome Measure Information:
Title
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary Outcome Measure Information:
Title
Survival time
Title
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
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A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
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