NCT01714089

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

First QC Date

October 19, 2012

Last Update Submit

April 5, 2016

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing remitting multiple sclerosisRR-MS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Change in number of T2 lesions from baseline

    Months 3, 4, 5, and 6

  • 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

  • +1 more secondary outcomes

Study Arms (3)

RNS60 125 ml

EXPERIMENTAL

125 ml of RNS60 administered weekly by IV infusion

Drug: RNS60 125 ml

RNS60 250 ml

EXPERIMENTAL

250 ml of RNS60 administered weekly by IV infusion

Drug: RNS60 250 ml

Interferon beta-1a

ACTIVE COMPARATOR

Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.

Drug: Interferon beta 1a

Interventions

RNS60 125 mlDRUG
RNS60 125 ml
RNS60 250 mlDRUG
RNS60 250 ml
Interferon beta 1aDRUG
Interferon beta-1a

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

RNS60Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Fred Lublin, MD, PhD

    Mt. Sinai School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 25, 2012

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)