Status:
COMPLETED
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Lead Sponsor:
Novartis
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Exclusion criteria as described in the original protocol will remain applicable into the extension protocol
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00230074
Start Date
November 1 2004
End Date
February 1 2005
Last Update
November 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis
East Hanover, New Jersey, United States, 07936