Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon Beta-1a

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment
Brain volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Brain volume by MRI over 6 months of treatment
T2 lesion volume [ Time Frame: 6 month ] [ Designated as safety issue: No ]
T2 lesion volume by MRI over 6 months of treatment
Annualized Relapse Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Annualized Relapse Rate over 6 months
Expanded Disability Status Scale (EDSS), change from baseline [ Time Frame: 3, 6 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.

Estimated Enrollment:	270
Study Start Date:	September 2013
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714089

Contacts

Contact: Tarah Gustafson

212-241-4264

Locations

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

Sponsors and Collaborators

Revalesio Corporation

Investigators

Principal Investigator:

Fred Lublin, MD, PhD

Mt. Sinai School of Medicine

More Information

No publications provided

Responsible Party:	Revalesio Corporation
ClinicalTrials.gov Identifier:	NCT01714089 History of Changes
Other Study ID Numbers:	06.1.1.H1
Study First Received:	October 19, 2012
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Revalesio Corporation:

Relapsing remitting multiple sclerosis
RR-MS

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta

Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 23, 2013