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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01714089
• Other study ID #: 06.1.1.H1
• Status: Withdrawn
• Phase: Phase 2
• First received: October 19, 2012
• Last updated: April 5, 2016

Study information

• Verified date: April 2016
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• RNS60 125 ml

• RNS60 250 ml

• Interferon beta 1a

Locations

Country	Name	City	State
United States	Mt. Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Revalesio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of GAD-enhancing lesions from baseline	Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6	3, 4, 5, and 6 months	No
Secondary	Change in number of T2 lesions from baseline	Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment	Months 3, 4, 5, and 6	No
Secondary	Brain volume	Brain volume by MRI over 6 months of treatment	6 months	No
Secondary	T2 lesion volume	T2 lesion volume by MRI over 6 months of treatment	6 month	No
Secondary	Annualized Relapse Rate	Annualized Relapse Rate over 6 months	6 months	No
Secondary	Expanded Disability Status Scale (EDSS), change from baseline	Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.	3, 6 months	Yes
Secondary	Multiple Sclerosis Functional Composite, change from baseline	Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.	3, 6 months	Yes