Neurological function in patients with MS will be evaluated during the course of repeated IVIg administration. The primary endpoint is changes from baseline in muscle strength at 6 months. On March 7, 1997, the Performance and Safety Monitoring Board of the NIH performed a site visit at Mayo Clinic, Rochester. At that point they had completed an interim analysis of the primary outcome measures for this study [recovery of muscle strength as measured by isometric muscle strength measurements]. Their analysis concluded that IVIG was not effective in reversing muscle weakness in this indication. They recommend discontinuing the protocol because of futility. In response to this, no additional patients were recruited or enrolled, and no additional infusions were given. We have now collected the final outcome measures on all enrolled patients.
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