A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Phase 2
Completed
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT00230074
- Lead Sponsor
- Novartis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
- Secondary Outcome Measures
Name Time Method Survival time Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States