Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis
NCT ID: NCT01714089
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RNS60 125 ml
125 ml of RNS60 administered weekly by IV infusion
RNS60 125 ml
RNS60 250 ml
250 ml of RNS60 administered weekly by IV infusion
RNS60 250 ml
Interferon beta-1a
Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.
Interferon beta 1a
Interventions
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RNS60 125 ml
RNS60 250 ml
Interferon beta 1a
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. No evidence of relapse during the 60 days prior to enrollment.
4. EDSS score of 0-5 at screening.
5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
6. 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.
7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.
Exclusion Criteria
2. Normal baseline brain MRI.
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
5. 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.
6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
7. Known allergy to Gadolinium-DTPA
8. 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.
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
18 Years
50 Years
ALL
No
Sponsors
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Revalesio Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Lublin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai School of Medicine
Locations
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Mt. Sinai School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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06.1.1.H1
Identifier Type: -
Identifier Source: org_study_id
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