OPEN-LABEL ARIMOCLOMOL EXTENSION PROTOCOL

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究是在完成12周治疗和第16周随访访视的患者中进行的AALS-001开放标签扩展研究。受试者将每天接受100 mg tid arimoclomol约6个月。访视将在筛选、基线时进行，每月一次，持续6个月（共8次访视）。第7个月的电话随访将结束受试者参与研究。 本研究的主要目的是确定长期使用的安全性问题。如果有一半的患者参与，则将有40名患者参与本研究，我们将有超过80%的机会看到至少一次发生频率超过4%的任何副作用。

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%.