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

Withdrawn before enrolling · Phase 2

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT01714089

Run by

Revalesio Corporation

People needed

0

Last updated by the study team

2016-04-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, aged between 18 and 50 years.
• Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
• No evidence of relapse during the 60 days prior to enrollment.
• EDSS score of 0-5 at screening.
• Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
• Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
• Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.

You may not qualify if…

• Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
• Normal baseline brain MRI.
• History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
• Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
• Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
• Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
• Known allergy to Gadolinium-DTPA
• Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
• Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
• Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
• Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
• Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.

Where it is running

• Mt. Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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