Enrollment targets have been met for the Phase III Study of Ceftriaxone.
Recruitment for this trial is now closed.

Enrollment targets have been met for the Phase III Study of Ceftriaxone. Recruitment for this trial is now closed.

A phase III trial has begun studying the efficacy of ceftriaxone, to see if it prolongs survival and/or slows decline in function in patients living with ALS. Ceftriaxone is an antibiotic in the class of cephalosporins that is approved to treat certain types of infections. Ceftriaxone may hold potential for ALS because the drug may also increase the level of a protein that decreases the level of glutamate - a potentially toxic nervous system messenger - near nerves, thereby protecting motor neurons from injury.

While ceftriaxone is approved for treating bacterial infections, the purpose of this trial is to evaluate the effectiveness of ceftriaxone as a treatment for ALS and to determine the safety of its long-term use. The phase III trial, which opened in May 2009, will enrol 600 participants for at least 12 months of ceftriaxone administration. It is a double-blind, placebo-controlled study, meaning that neither participants nor investigators will know who is receiving ceftriaxone and who is receiving the placebo. Two thirds of participants will receive treatment with ceftriaxone and one third will receive the placebo. Ceftriaxone is an intravenous medication, so participants will have a catheter inserted in a vein through which the medication is administered. Participants will take tests at regular intervals throughout the study to examine their strength and vital capacity.

Funded and run by the Northeast ALS Consortium (NEALS), the multi-centre trial is taking place at ALS clinics across the United States and Canada. The principal investigator in this trial is Merit Cudkowicz, M.D., at Massachusetts General Hospital. The co-principal investigators are Swati Aggarwal, M.D., at Massachusetts General Hospital, and Jeremy Shefner, M.D., Ph.D., at SUNY Upstate Medical Center. Lorne Zinman, MD, medical director of the ALS Clinic at the Sunnybrook Health Sciences Centre and assistant professor at the University of Toronto, is the Canadian principal investigator.

For a listing of trial centres please click here