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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00230074 |
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.
Condition | Intervention | Phase |
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Amyotrophic Lateral Sclerosis |
Drug: TCH346 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS) |
Estimated Enrollment: | 500 |
Study Start Date: | November 2004 |
Study Completion Date: | February 2005 |
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.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Study ID Numbers: | CTCH346A2211E1 |
Study First Received: | September 28, 2005 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00230074 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Amyotrophic Lateral Sclerosis; ALS |
Lou Gehrig's Disease Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases |
Sclerosis Neurodegenerative Diseases Degenerative Motor System Disease Motor Neuron Disease |
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |