Clinical Trial: Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis

Brief Summary: The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.

Detailed Summary:
Sponsor: Revalesio Corporation

Current Primary Outcome: Change in number of GAD-enhancing lesions from baseline [ Time Frame: 3, 4, 5, and 6 months ]

Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in number of T2 lesions from baseline [ Time Frame: Months 3, 4, 5, and 6 ]
    Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment
  • Brain volume [ Time Frame: 6 months ]
    Brain volume by MRI over 6 months of treatment
  • T2 lesion volume [ Time Frame: 6 month ]
    T2 lesion volume by MRI over 6 months of treatment
  • Annualized Relapse Rate [ Time Frame: 6 months ]
    Annualized Relapse Rate over 6 months
  • Expanded Disability Status Scale (EDSS), change from baseline [ Time Frame: 3, 6 months ]
    Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.
  • Multiple Sclerosis Functional Composite, change from baseline [ Time Frame: 3, 6 months ]
    Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.


Original Secondary Outcome: Same as current

Information By: Revalesio Corporation

Dates:
Date Received: October 19, 2012
Date Started:
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016