| First Published on Clinicaltrials.gov: |
4/7/2009 |
| Status: |
Currently Recruiting |
| ClinicalTrials.gov ID: |
NCT00877604 |
| Sponsor: |
Istittuto Nazionale Neurologico Carlo Besta |
| Purpose: |
The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant, antiapoptotic and neuroprotective properties of TUDCA in the central nervous system (CNS), both in vitro and in vivo models. |
| Phase: |
II |
| Treatment Type: |
Orally available in pill form |
| Trial Type: |
Double Blind, Placebo Control |
| Estimated Enrollment: |
26 |
| Eligibility: |
18 years to 75 years. Both Genders. No healthy volunteers. |
| Details: |
Two arm study: experimental oral route does of tauroursodeoxycholic acid (TUDCA) at 1 g b.i.d. (2 g daily) for 1 year, placebo comparator by oral route at the same dosing schedule. |
| Collaborator(s): |
- University of Palermo Federico II University
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| Location(s): |
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| Primary Investigator: |
Alberto Albanese, MD Fondazione IRCCS Istituto neurologico Carlo Besta |
| Contact: |
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| Trial Protocol as Published on Clinicaltrials.gov: |
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| ALS Forum: |
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