Detalles del proyecto
Description
The purpose of this study is to determine whether the use of a high dose of minocycline
slows the degeneration of neurons in patients with Amyotrophic Lateral Scierosis. This a
multi-center double-blind study whose Principal Investigator is Dr. Paul H. Gordon of
Columbia University. The study aims to have a total of 400 patients achieve
randomization (the Month 4 visit); 200 will receive placebo and 200 will receive active
minocycline. There are 13 study visits in total. Study procedures include blood tests,
physical and neurological exams, muscle and breathing testing, and quality of life
questionnaires.
Dr. Gordon will be in charge of cond~cting the overall project and all site CQinvestigators
shall work with him to'fulfill the objectives of the project. Eacb site
investigator will be reSponsible for the supervision of the study visits, infonned consent
procedures, source documentation, JRB approval, and regulatory documents at hislher
site in accordance with the Manual of Operations, Good Clinical Practices, NIH
guidelines, and FDA regulations.
| Estado | Finalizado |
|---|---|
| Fecha de inicio/Fecha fin | 5/25/03 → 5/31/07 |
Huella digital
Explore los temas de investigación que se abordan en este proyecto. Estas etiquetas se generan con base en las adjudicaciones/concesiones subyacentes. Juntos, forma una huella digital única.