MR-C-014 for Neuromyelitis Optica

(aNiMatO Trial)

Recruiting 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

30 Participants Needed

Trial Summary

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 safety data exists for MR-C-014 or similar treatments?

In a trial for a similar treatment, an altered peptide ligand, 9% of patients experienced hypersensitivity reactions (allergic reactions), leading to the trial's suspension. However, there were no increases in disease activity or new lesions in these patients. ^{1 2 3 4 5}

What is the purpose of this 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) who have a gait deficit.

Research Team

Eric C. Klawiter, MD, MSc

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Induction of a non-encephalitogenic type 2 T helper-cell autoimmune response in multiple sclerosis after administration of an altered peptide ligand in a placebo-controlled, randomized phase II trial. The Altered Peptide Ligand in Relapsing MS Study Group. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance during treatment of multiple sclerosis: early recognition of CNS complications. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Acute allergic reaction upon first exposure to gadolinium-DTPA: a case report. [2019]