The Eleanor and Lou Gehrig MDA/ALS Research Center will coordinate an upcoming multi-center Phase II Selection Trial of Combination Drug Therapy in ALS. The trial is funded by the ALS Association and set to begin in July 2006. It will be conducted at 20 ALS Centers across the nation, including Columbia University.

Q: What is a Selection Trial?
A: A selection trial allows researchers to simultaneously study groups of medications with the goal of selecting the better treatment. Selection trials use a smaller number of people and can possibly end early with selection of a promising treatment.

In this trial, there is no placebo, so every patient will receive an active combination of drugs. The combination that helps patients more will be identified in the analysis.

Q: What are the enrollment requirements?
A: Eligible participants will:
• Have a Forced Vital Capacity (FVC – a respiratory test) > 60%
• Have ALS onset within the past 5 years
• Not be taking minocycline, tetracyclines, celecoxib, creatine, other investigational therapies or be in another clinical trial

Q: What medications are used?
A: In this trial, we will determine whether one combination (minocycline/creatine or celecoxib/creatine) is more effective in treating ALS. We will also establish whether the combinations are safe and well tolerated with riluzole.

For more information about the trial contact:
Carolyn Doorish, Project Coordinator
E-mail: cd2141@columbia.edu
Phone: (212) 305-2027