NCT01714089WithdrawnPhase 2
A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Revalesio Corporation
- Locations
- 1
- Primary Endpoint
- Change in number of GAD-enhancing lesions from baseline
Study Overview
Brief Summary
The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
RNS60 250 ml
Experimental
250 ml of RNS60 administered weekly by IV infusion
Intervention: RNS60 250 ml (Drug)
RNS60 125 ml
Experimental
125 ml of RNS60 administered weekly by IV infusion
Intervention: RNS60 125 ml (Drug)
Interferon beta-1a
Active Comparator
Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.
Intervention: Interferon beta 1a (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Change in number of T2 lesions from baseline(Months 3, 4, 5, and 6)
- Multiple Sclerosis Functional Composite, change from baseline(3, 6 months)
- Brain volume(6 months)
- T2 lesion volume(6 month)
- Annualized Relapse Rate(6 months)
- Expanded Disability Status Scale (EDSS), change from baseline(3, 6 months)
Investigators
Study Sites (1)
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