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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714089
First Posted: October 25, 2012
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Revalesio Corporation
  Purpose
The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: RNS60 125 ml Drug: RNS60 250 ml Drug: Interferon beta 1a Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Arms Assigned Interventions
Experimental: RNS60 125 ml
125 ml of RNS60 administered weekly by IV infusion
Drug: RNS60 125 ml
Experimental: RNS60 250 ml
250 ml of RNS60 administered weekly by IV infusion
Drug: RNS60 250 ml
Active Comparator: Interferon beta-1a
Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.
Drug: Interferon beta 1a

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714089


Locations
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Revalesio Corporation
Investigators
Principal Investigator: Fred Lublin, MD, PhD Mt. Sinai School of Medicine
  More Information

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT01714089     History of Changes
Other Study ID Numbers: 06.1.1.H1
First Submitted: October 19, 2012
First Posted: October 25, 2012
Last Update Posted: April 6, 2016
Last Verified: April 2016

Keywords provided by Revalesio Corporation:
Relapsing remitting multiple sclerosis
RR-MS

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic