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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]
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