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

Information source: Revalesio Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: RNS60 125 ml (Drug); RNS60 250 ml (Drug); Interferon beta 1a (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Revalesio Corporation

Official(s) and/or principal investigator(s):
Fred Lublin, MD, PhD, Principal Investigator, Affiliation: Mt. Sinai School of Medicine

Overall contact:
Tarah Gustafson, Phone: 212-241-4264

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in number of GAD-enhancing lesions from baseline

Secondary outcome:

Change in number of T2 lesions from baseline

Brain volume

T2 lesion volume

Annualized Relapse Rate

Expanded Disability Status Scale (EDSS), change from baseline

Multiple Sclerosis Functional Composite, change from baseline

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males or females, aged between 18 and 50 years. 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: 1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS. 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.

Locations and Contacts

Tarah Gustafson, Phone: 212-241-4264

Mt. Sinai School of Medicine, New York, New York 10029, United States; Not yet recruiting
Fred Lublin, MD, PhD, Principal Investigator
Additional Information

Starting date: October 2016
Last updated: May 4, 2015

Page last updated: August 20, 2015

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