MULTI-DOSE PLACEBO-CONTROLLED PHASE I STUDY OF AEOL 10150 IN PATIENTS WITH ALS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Amyotrophic Lateral Sclerosis (ALS) is a devastating neurological disease without a known sure. AEOL 10150 is a manganoporphrin antioxidant that destroys reactive-oxygen species potentially implicated in ALS. This study will determine the safety, tolerability, and pharmacokinetic profile of AEOL 10150 (at 40, 70, and 100 mg SC for six days, then qd for day seven) compared with placebo in patients with ALS and help determine the maximum tolerated dose for an efficacy trial.