drugset / Trial / NCT00072709
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).
Timeline
- Start
- 2003-09
- Primary completion
- 2004-12
- Completion
- 2004-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omigapil | Small molecule | 1 mg | Oral |
| Subject | Omigapil | Small molecule | 2.5 mg | Oral |
| Subject | Omigapil | Small molecule | 7.5 mg | Oral |
| Subject | Omigapil | Small molecule | 15 mg | Oral |