MR-C-014 for Neuromyelitis Optica

(aNiMatO Trial)

Enrolling by invitation at 1 trial location

Overseen By Sabrina Taylor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedRhythms, Inc.

Must not be taking: Dalfampridine, Corticosteroids, Spasticity meds

Disqualifiers: Pregnancy, Prosthetic limb, Recent relapse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MR-C-014 for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD) who have difficulty walking. The main goal is to determine if the treatment is safe and acceptable. Participants will use MR-C-014 in 24 sessions over eight weeks to assess its impact on walking ability. Individuals with NMOSD who have a noticeable walking issue and can walk at a specific speed may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance walking abilities for those with NMOSD.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot have started, changed, or stopped any disease-modifying therapy affecting gait in the past 3 months.

What prior data suggests that MR-C-014 is safe for individuals with Neuromyelitis optica spectrum disorder?

Research is currently investigating MR-C-014 to determine its safety and suitability for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD) who have difficulty walking. Although detailed safety information from earlier studies is not available, the trial is in an early phase. Researchers are primarily focused on ensuring the treatment is safe and well-tolerated by participants. At this stage, they will closely monitor and report any serious side effects. The main goal is to ensure MR-C-014 does not cause harm and is manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Neuromyelitis Optica, which generally involve immunosuppressive therapies like rituximab or corticosteroids, MR-C-014 offers a novel approach. This treatment is administered over 24 sessions of just 30 minutes each, three times a week for eight weeks, potentially offering a more convenient regimen. Researchers are excited about MR-C-014 because it might provide a targeted treatment option with fewer systemic side effects, improving patients' quality of life while effectively managing the condition.

What evidence suggests that MR-C-014 might be an effective treatment for Neuromyelitis Optica?

Research has shown that MR-C-014 is under study as a potential treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD affects the nerves in the eyes and spinal cord, leading to issues like vision loss and difficulty walking. In this trial, participants will use MR-C-014 for 24 sessions, each lasting 30 minutes, three times a week for eight weeks. As a new treatment, scientists are investigating its potential to alleviate symptoms such as trouble walking. Although information on MR-C-014 remains limited, the study aims to assess its tolerability and effectiveness in improving symptoms for people with NMOSD. This treatment is still in the early testing stages, requiring further research to confirm its efficacy. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric C. Klawiter, MD, MSc

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD) who have difficulty walking. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of NMOSD.

Inclusion Criteria

I have been diagnosed with Transverse Myelitis in the past.

Meets revised diagnostic criteria for NMOSD proposed by the International Panel for NMO Diagnosis (IPND) in 2015

Able to read and/or understand English

Exclusion Criteria

People who become pregnant or are pregnant (due to expected changes in gait patterns)

I have had a recent flare-up of my NMOSD or was hospitalized for it in the last 3 months.

I am willing and able to follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the MR-C-014 device for 24 sessions, 3 times a week for 8 weeks

8 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MR-C-014

Trial Overview The study is testing the acceptability and safety of a new intervention called MR-C-014 in people with NMOSD. The focus is on how well patients tolerate this treatment and its safety profile.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will be asked to use MR-C-014 for 24 sessions (30 minutes each), 3 times a week for 8 weeks.

Who Is Running the Clinical Trial?

MedRhythms, Inc.

Lead Sponsor

Trials

7

Recruited

440+

Alexion Pharmaceuticals, Inc.

Industry Sponsor

Trials

267

Recruited

141,000+

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Published Research Related to This Trial

Gadolinium-based contrast agents (GBCAs) have a strong safety record in MRI imaging, but there are known risks such as acute adverse reactions and nephrogenic systemic fibrosis that require ongoing management and understanding.

The review highlights that certain populations, including those with kidney issues, are at higher risk for complications from GBCAs, and it also discusses the emerging use of ferumoxytol as a non-GBCA alternative with its own risk profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. Ponrartana, S., Moore, MM., Chan, SS., et al.[2021]

This case report highlights an allergic reaction to Gadolinium-DTPA, a contrast agent used in MRI scans, occurring upon the first exposure, emphasizing the need for awareness of potential allergic responses.

The report includes a review of the safety profile of MR contrast agents, suggesting that while they are generally safe, individual reactions can occur, warranting careful monitoring during their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute allergic reaction upon first exposure to gadolinium-DTPA: a case report. Rahman, SL., Harbinson, MT., Mohiaddin, R., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06374264

NCT06374264 | Acceptability and Safety of MR-C-014 in ... The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) ...

2. withpower.com withpower.com/trial/mr-c-014-for-neuromyelitis-optica-27f24

MR-C-014 for Neuromyelitis Optica (aNiMatO Trial) The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316463/

Long-Term Efficacy and Safety of Satralizumab in Patients ... This study provides Class IV evidence that SAT is safe and effective in patients with NMOSD. Introduction. Neuromyelitis optica spectrum ...

4. ctv.veeva.com ctv.veeva.com/study/acceptability-and-safety-of-mr-c-014-in-persons-with-neuromyelitis-optica-spectrum-disorder

Acceptability and Safety of MR-C-014 in Persons With ... The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica ...

5. link.springer.com link.springer.com/article/10.1007/s00415-023-11910-z

Update on the diagnosis and treatment of neuromyelitis ... This manuscript presents practical recommendations for managing acute attacks and implementing preventive immunotherapies for neuromyelitis optica spectrum ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0067761

Neuromyelitis Optica Spectrum Disorders ... Associated Data ; NCT04155424. A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836138/

Advances in the long-term treatment of neuromyelitis optica ... ... NMO patients. Due to the safety data discussed, it is recommended that immunoglobulin levels and CBC with differential be monitored at each ...