From The ALS Association National Office:
Screening Effort Identified Ceftriaxone as Potential ALS Therapeutic:
“Clinical Trial Plans - Questions and Answers”
Q: Should I ask my doctor to prescribe Ceftriaxone (Rocephin) or another similar antibiotic for me to take?
A: No, the researchers doing this study and other ALS clinical experts
agree that it is premature for patients to take Ceftriaxone for ALS. The clinical trial being planned is designed to answer the question of whether or not ceftriaxone is safe when used for long periods of time and has a positive effect for people with ALS. The information published in the January issue of the journal Nature, and described in the ALSA release above, is experimental.
Q: How can I learn more about the clinical trial and find out about
enrolling?
A: Planning has begun for a clinical trial of ceftriaxone. The study will be conducted by the Northeast ALS consortium and several other US and Canadian ALS centers. It will be funded by the National Institutes for Neurological Diseases and Stroke (NINDS). It is anticipated that the clinical trial will include 600 people with ALS at 46 ALS centers throughout the U.S. and Canada. A preliminary study is planned initially at 8 clinical ALS centers to evaluate the safety of the amounts of the drug that are planned to be given in the study.
The investigators are currently seeking regulatory (Food and Drug
Administration) approval to conduct this clinical drug study. They are
hopeful that patient enrollment will begin in the spring or summer of
2005.
The principle investigator of the clinical trial grant from NINDS is Merit Cudkowicz, MD from Massachusetts General Hospital. The Co-investigators are Jeffrey Rothstein, MD, PhD from Johns Hopkins and Jeremy Shefner, MD, PhD from Upstate Medical University, Syracuse.
The Project Managers for the study are Amy Swartz (alswartz@partners.org) and Mary O’Brien (mobrien13@partners.org) from Massachusetts General Hospital.
For more information, they can be reached at (617) 726-9122 or
by e-mail.