Wellness Program for Neuromyelitis Optica Spectrum Disorder

(NMOSD Trial)

Overseen By Susan Filomena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Stimulants, Dalfampridine

Disqualifiers: Age <18, Recent relapse, others

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

Compensation: Varies

Number of Visits: 24

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a structured wellness program can improve daily life for people with Neuromyelitis Optica Spectrum Disorder (NMOSD). The program includes support from various healthcare specialists, such as physical therapists and dietitians, to enhance overall quality of life. Participants will be divided into two groups: one will start the program immediately, while the other will begin after six months. Individuals diagnosed with NMOSD based on 2015 criteria and able to participate in study evaluations are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to understanding how wellness programs can benefit those with NMOSD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients who start certain new medications like stimulants or dalfampridine after enrolling will be excluded.

What prior data suggests that this wellness program is safe for NMOSD patients?

Research has shown that wellness programs, like the one being tested for Neuromyelitis Optica Spectrum Disorder (NMOSD), have improved quality of life in other areas. These programs typically involve support from professionals such as physical therapists and dietitians. No specific data from clinical trials indicate safety issues for this wellness program in NMOSD patients. However, wellness programs generally include non-invasive activities like exercise, diet, and mental health support, which participants usually tolerate well.

This trial is marked as "Not Applicable" in terms of phase, indicating a focus on improving quality of life rather than testing a new drug or procedure. Wellness programs for other conditions have shown positive results without major safety concerns. Participants can expect similar safety and tolerance with this NMOSD program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wellness Program for Neuromyelitis Optica Spectrum Disorder (NMOSD) because it focuses on holistic care rather than solely on medication. Unlike typical treatments for NMOSD, which often include immunosuppressive drugs, this program emphasizes wellness services and behavioral interventions. This approach aims to improve overall quality of life and potentially reduce symptoms by addressing lifestyle factors. By targeting wellness and behavior, the program offers a complementary strategy that could work alongside existing medical treatments to enhance patient outcomes.

What evidence suggests that this wellness program is effective for improving quality of life in Neuromyelitis Optica Spectrum Disorder?

Research has shown that wellness programs can greatly improve life for people with long-term conditions like Neuromyelitis Optica Spectrum Disorder (NMOSD). These programs often include physical therapy, dietary advice, and mental support, which help manage symptoms and boost overall well-being. Although direct studies on NMOSD are limited, similar programs for people with multiple sclerosis have improved mental and physical health. This trial will compare two approaches: an Immediate Start group, where participants begin wellness program services and behavioral interventions immediately, and a Delayed Start group, where participants experience a 6-month delay before starting the program. These programs are designed to meet both physical and mental health needs, offering a comprehensive approach to care. Early results suggest that these programs can significantly enhance life quality for those with NMOSD. ^{2 5 6 7 8}

Who Is on the Research Team?

Sammita Satyanarayan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD). Participants should be willing to engage in a wellness program that includes physical therapy, dietary advice, social support, nursing care, and cognitive therapy. The study excludes details on specific inclusion or exclusion criteria.

Inclusion Criteria

All patients regardless of treatment type will be considered

My level of disability will not exclude me from this study.

I am an adult diagnosed with NMOSD according to 2015 criteria.

Exclusion Criteria

Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention

I am unable to give my consent to participate in the study on my own.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a structured wellness program intervention tailored to NMOSD patients, including services from physical therapists, dietitians, social workers, nurse practitioners, and cognitive therapists.

6 months

Assessments at baseline, 12 weeks, and 6 months

Follow-up

Participants are monitored for sustainability of the wellness program, with assessments of quality of life, mobility, vision, exercise, and diet.

6 months

Assessments at 12 months and 18 months

Open-label extension (optional)

Participants may opt into a one-year extension study, receiving additional wellness interventions and bimonthly behavioral counseling sessions.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Wellness Program

Trial Overview

The trial tests a structured wellness program's impact on NMOSD patients' quality of life. It involves random assignment to either start the program immediately or after a six-month delay, using the MS-Quality of Life-54 as the primary measure of success.

How Is the Trial Designed?

Group I: Immediate Start Experimental Treatment 1 Intervention

Participants will begin wellness program services and behavioral interventions immediately after randomization

Group II: Delayed Start Experimental Treatment 1 Intervention

Participants will experience a 6-month delay in receiving wellness program services and behavioral interventions.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

A wellness program for people with multiple sclerosis (MS) showed significant improvements in various health domains, including functional status, fatigue, and depression, based on data from 65 participants.

The program's focus on education and self-efficacy helped reduce fear-avoidance beliefs and pain, suggesting that a multidimensional approach can enhance overall well-being in MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a wellness program for people with multiple sclerosis: description and initial results. Hart, DL., Memoli, RI., Mason, B., et al.[2021]

The N-MOmentum trial is investigating the safety and efficacy of MEDI-551, an anti-CD19 monoclonal antibody, in patients with neuromyelitis optica spectrum disorder (NMOSD), with a focus on minimizing patient exposure to placebo over a treatment period of up to 197 days.

This trial employs innovative statistical methods and interim analyses to ensure robust results while addressing the unique challenges of NMOSD clinical trials, aiming to accurately assess treatment effects and reduce risks for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical Considerations for an Adaptive Design for a Serious Rare Disease. Patra, K., Cree, BAC., Katz, E., et al.[2020]

The Optimise:MS study has recruited over 2,000 participants from 14 hospitals in the UK to assess the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in real-world settings, focusing on serious adverse events (SAEs).

The study's statistical analysis plan is designed to address complex confounding factors and will provide valuable insights into the long-term outcomes of DMTs, including the effects of treatment switching and pregnancy outcomes, which are often not covered in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. Waddingham, E., Miller, A., Dobson, R., et al.[2022]

A 4-day interdisciplinary wellness program for 129 individuals with multiple sclerosis (MS) led to significant improvements in self-efficacy and health-related quality of life (QOL) that were sustained for at least 6 months after the intervention.

The improvements in self-efficacy and QOL were consistent across participants regardless of their level of disability, indicating that the program is beneficial for all individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy and health status improve after a wellness program in persons with multiple sclerosis. Ng, A., Kennedy, P., Hutchinson, B., et al.[2015]

A wellness program designed for women with multiple sclerosis (MS) effectively promotes health by providing tailored knowledge and enhancing self-efficacy for health behaviors.

Participants in the two-phase intervention, which included knowledge-building classes and telephone follow-ups, reported positive changes in their health and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting wellness for women with multiple sclerosis. Stuifbergen, A., Becker, H., Rogers, S., et al.[2019]

Citations

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Advances in the treatment of neuromyelitis optic spectrum ...

Retrospective data showed that ISTs reduce the relapse risk in NMOSD, with MMF demonstrating greater efficacy compared to other oral drugs.

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The Alexion-sponsored global NMO SPOTLIGHT Registry (NCT05966467) collects ALXN-C5IT real-world safety and clinical effectiveness data in adults ...

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Preferences for neuromyelitis optica spectrum disorder ...

The aim of this study was to assess neurologists' preferences for different NMOSD treatment attributes using conjoint analysis (CA).

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Advances in the therapeutic landscape for neuromyelitis ...

Eighty-three patients with NMOSD (66% AQP4-IgG positive) with ≥2 relapses in the 2 years prior to screening, and at least 1 relapse in the preceding 12 months ...

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Although studies suggest therapeutic benefit, no treatment of NMOSD has been found to be safe and effective in prospective, adequately powered ...

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Impact of a Structured Wellness Behavioral Intervention on ...

This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04660539

NCT04660539 | A Study to Evaluate the Safety and ...

This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica ...