Trial Information

Summary: Multi-center Phase II Combination Therapy Selection Trial In ALS

The Investigator-initiated trial is set to begin in Spring 2006 and will be conducted at 20 ALS Centers across the nation, including Columbia University. The researchers will enroll 120 participants nationwide.

Each participant will have monthly evaluations for 6 months measuring safety and changes in function. Participants will be allowed to take riluzole, but not other investigational agents during the trial.

Scientific Background:

Excess free radicals, energy mishandling, excitotoxicity, activation of cell death pathways and inflammation likely all contribute to neurodegeneration in ALS. Past trials may have been negative in part because they tested single agents, usually influencing only one mechanism of cell death. Combinations of agents that affect different and multiple mechanisms of neurodegeneration may be necessary to reach meaningful outcomes in trials of ALS.

This trial has several unique features. First, it compares the neuroprotective potential of two combinations of agents that impact multiple mechanisms of cell death. The combinations of minocycline/creatine and celecoxib/creatine are the only agents that have had additive effects in the mouse model of ALS, reducing neurodegeneration and prolonging survival more than individual agents alone. Second, it uses an important new phase II selection trial design to determine which combination is superior. Not only does this trial test combination therapy, but there is no placebo, so that everyone who enrolls in the trial will receive active treatment.

Preliminary Human Trials

Minocycline, creatine and celecoxib have been tested individually in early phase trials and have been shown to be safe in patients with ALS. This will be the first time that human trials will be conducted with combinations of minocycline/creatine and celecoxib/creatine.

Importance:

There is no cure for ALS. It is only through well-designed clinical trials that more effective treatments will be found. Clinical trials are entirely dependent upon the participation of patients with ALS.

We will compare combinations of drugs in a phase II trial design to determine which combination is superior. If successful, this trial will lead directly to a phase III trial of the selected combination. If the design is found useful, this trial will lead to larger phase II selection trials assessing greater numbers of agents simultaneously, thereby improving the efficiency of drug screening in ALS.

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