OPEN-LABEL ARIMOCLOMOL EXTENSION PROTOCOL

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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. This study is an open-label extension of AALS-001 in those patients who completed 12 weeks of treatment and the Week 16 Follow-up Visit. Subjects will receive 100 mg tid arimoclomol daily for approximately six months. Visits will occur at Screening, Baseline, and once a month for six months (total of 8 visits). A telephone call follow-up at Month 7 will end subject participation in the study. The primary purpose of this study is to identify safety problems with long-term use. If half the patients participate there will be 40 patients on this study and we will have over an 80% chance of seeing at least one occurrence of any side effect that occurs with a frequency of over 4%.