Relapsing Remitting Multiple SclerosisPhase 2NCT01714089
Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis
A Phase 2 study testing RNS60 125 ml, RNS60 250 ml and Interferon beta 1a in people with Relapsing Remitting Multiple Sclerosis, run by Revalesio Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- RNS60 125 ml, RNS60 250 ml and Interferon beta 1a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mt. Sinai School of Medicine
New York, New York, 10029
About this study
Official title: A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis
The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- RNS60 125 ml, RNS60 250 ml, Interferon beta 1a
- Keywords
- Relapsing remitting multiple sclerosis, RR-MS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS60 125 mlDrug
RNS60 250 mlDrug
Interferon beta 1aDrug
| Study group | Role | What they receive |
|---|---|---|
| RNS60 125 ml | Experimental | 125 ml of RNS60 administered weekly by IV infusion Receives: Drug: RNS60 125 ml |
| RNS60 250 ml | Experimental | 250 ml of RNS60 administered weekly by IV infusion Receives: Drug: RNS60 250 ml |
| Interferon beta-1a | Active comparator | Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection. Receives: Drug: Interferon beta 1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of GAD-enhancing lesions from baseline
Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6
Measured: 3, 4, 5, and 6 months
Secondary outcomes (6)
Change in number of T2 lesions from baseline
Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment
Measured: Months 3, 4, 5, and 6
Brain volume
Brain volume by MRI over 6 months of treatment
Measured: 6 months
T2 lesion volume
T2 lesion volume by MRI over 6 months of treatment
Measured: 6 month
Annualized Relapse Rate
Annualized Relapse Rate over 6 months
Measured: 6 months
Expanded Disability Status Scale (EDSS), change from baseline
Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.
Measured: 3, 6 months
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.
Measured: 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Lublin, MD, PhD, Principal investigator, Mt. Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714089
- Sponsor's protocol ID
- 06.1.1.H1
- Status last verified
- Apr 2016
- First submitted
- 19 Oct 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01714089
- Acronym / sponsor ID
- 06.1.1.H1
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing remitting multiple sclerosis, RR-MS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RNS60 125 ml | Experimental | Drug: RNS60 125 ml125 ml of RNS60 administered weekly by IV infusion |
| RNS60 250 ml | Experimental | Drug: RNS60 250 ml250 ml of RNS60 administered weekly by IV infusion |
| Interferon beta-1a | Active comparator | Drug: Interferon beta 1aWeekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNS60 125 ml | Drug | RNS60 125 ml |
| RNS60 250 ml | Drug | RNS60 250 ml |
| Interferon beta 1a | Drug | Interferon beta-1a |
Primary outcome
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
6 secondary outcomes
Change in number of T2 lesions from baseline
Time frame: Months 3, 4, 5, and 6
Brain volume
Time frame: 6 months
T2 lesion volume
Time frame: 6 month
Annualized Relapse Rate
Time frame: 6 months
Expanded Disability Status Scale (EDSS), change from baseline
Time frame: 3, 6 months
Multiple Sclerosis Functional Composite, change from baseline
Time frame: 3, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Lublin, MD, PhD principal investigator
Mt. Sinai School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNS60 125 ml, RNS60 250 ml and Interferon beta 1a in people with Relapsing Remitting Multiple Sclerosis, run by Revalesio Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of GAD-enhancing lesions from baseline (time frame: 3, 4, 5, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.