Clinical trial NCT01714089: Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis
Official title: A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing remitting multiple sclerosis
RR-MS
Lead sponsor: Revalesio Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in number of GAD-enhancing lesions from baseline
timeFrame: 3, 4, 5, and 6 months
Secondary outcomes:
measure: Change in number of T2 lesions from baseline
timeFrame: Months 3, 4, 5, and 6
measure: Brain volume
timeFrame: 6 months
measure: T2 lesion volume
timeFrame: 6 month
measure: Annualized Relapse Rate
timeFrame: 6 months
measure: Expanded Disability Status Scale (EDSS), change from baseline
timeFrame: 3, 6 months
measure: Multiple Sclerosis Functional Composite, change from baseline
timeFrame: 3, 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
Study officials:
affiliation: Mt. Sinai School of Medicine
name: Fred Lublin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: