CLINICAL TRIAL

Treatment for Multiple Sclerosis

1 Prior Treatment
Relapsed
Recruiting · 18 - 65 · All Sexes · Buffalo, NY

This study is evaluating whether a drug called Mayzent can reduce the number of activated microglia in the brain of people with multiple sclerosis.

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About the trial for Multiple Sclerosis

Eligible Conditions
Neoplasm Metastasis · Multiple Sclerosis · Sclerosis · Multiple Sclerosis, Chronic Progressive · Secondary Progressive Multiple Sclerosis (SPMS)

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
Ocrevus
DRUG
Control Group 2
Mayzent
DRUG

Eligibility

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Multiple Sclerosis or one of the other 4 conditions listed above. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients diagnosed with active SPMS according to the Lublin 2014 criteria. Activity is determined by MRI activity (contrast-enhancing lesions; new and unequivocally enlarging T2 lesions) and/or clinical relapses in the 24 months prior to the study baseline. If the clinical MRI is not available to determine the activity (contrast-enhancing lesions; new and unequivocally enlarging T2 lesions), then a screening MRI will be offered to the subjects to determine inclusion/
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6, 12, 24 and 36 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, 24 and 36 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6, 12, 24 and 36 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome, 2 secondary outcomes, and 11 other outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of 12 months.

Change from baseline in PET Activation at 12 Months
12 MONTHS
Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients under treatment with Mayzent when 100% of patients reach 12 months;
12 MONTHS
Association between imaging and clinical and cognitive outcomes
24 AND 36 MONTHS
The association between imaging and clinical and cognitive outcomes, incl. the composite EDSS+SDMT, over 24 and 36 months of the study
24 AND 36 MONTHS
Number of participants with Treatment related adverse events
12, 24, AND 36 MONTHS
Safety of Mayzent and active control group over 12, 24, and 36 months of the study
12, 24, AND 36 MONTHS
MRI Measures between Mayzent and control-treated groups (QSM)
12, 24 AND 36 MONTHS
Quantitative susceptibility mapp (QSM) change between baseline and 12, 24, and 36 months
12, 24 AND 36 MONTHS
MRI Measures between Mayzent and control-treated groups(PTVC)
12, 24 AND 36 MONTHS
Percent thalamus volume change (PTVC) between baseline and 12, 24, and 36 months
12, 24 AND 36 MONTHS
MRI Measures between Mayzent and control-treated groups (PCVC)
12, 24 AND 36 MONTHS
Percent cortical volume change (PCVC), between baseline and 12, 24, and 36 months
12, 24 AND 36 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the average age someone gets multiple sclerosis?

There is a significant increase in the percentage of women with relapsing-remitting multiple sclerosis (RRMS) after age 45 compared with age 20. This may suggest that women tend to get RRMS later in life.

Anonymous Patient Answer

What is the primary cause of multiple sclerosis?

There is no single cause of MS. Many factors are involved in the development of MS. The specific mechanisms underlying progression from clinically isolated syndrome (CIS) to MS are still unclear. But there are some factors associated with a worse prognosis like younger age at onset, sporadic course, depression, and facial features.\n

Anonymous Patient Answer

How many people get multiple sclerosis a year in the United States?

About 2,300 people are diagnosed with multiple sclerosis annually in the U.S. This is based on the list of coded conditions in the National Inpatient Sample. It is likely to be an underestimate because some cases may not have been recorded, especially if they are self-reported. The number of new cases per million inhabitants per year ranged from 0.5 in 2005 to 5.0 in 2007. This article is protected by copyright. All rights reserved.

Anonymous Patient Answer

Does treatment improve quality of life for those with multiple sclerosis?

Patients with MS report significant improvements in HRQoL with better mobility and physical functioning as well as satisfaction with care, compared with health assessment before starting treatment. Results from a recent paper demonstrate that treatment has a positive impact on individuals' HRQoL.

Anonymous Patient Answer

What is the survival rate for multiple sclerosis?

Survival rate is high, but it depends on many factors including gender, age at onset of MS, disease type, EDSS score, and RRMS versus SPMS diagnosis. Most recent studies estimate a 5-year survival rate of 85% for women and 77% for men. Men with relapsing-remitting MS (RRMS) have a better prognosis than women or progressive MS patients. Women with RRMS have a relatively poor prognosis compared to men. MS patients younger than the age of 30 years have a worse prognosis than those older than 50 years.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

The newest generation of anti-TNF therapies has been shown to significantly reduce relapses, disability progression, and new lesion development compared with placebo. This data supports the notion that TNF inhibitors are effective in preventing clinical relapses. Another recent advance has been the introduction of teriflunomide as an oral medication. Teriflunomide was approved by the FDA in 2010 for the treatment of MS patients whose disease failed to improve after two prior treatments with interferon beta-1a or -b. Other agents approved for the treatment of MS include fingolimod, natalizumab, mitoxantrone, and alemtuzumab.

Anonymous Patient Answer

Who should consider clinical trials for multiple sclerosis?

The majority of patients found to be eligible for trial were considered to have a relatively good prognosis. However, there was considerable heterogeneity in the outcome measures used by the various centres. There is therefore a need for a standardised methodology to be used in future clinical trials.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple sclerosis?

There have been several medications shown to be effective in MS. In fact, many of these drugs have made it to the market. Still, there are certain drawbacks with current treatments for MS. Some of these include high doses of medication, long-term use of the same medication, side effects, and adherence issues. There are also some ongoing clinical trials looking at combination therapies that combine different medications into one. These newer therapies may make it easier for people with MS to take medications more efficiently, reduce side effects, and hopefully increase treatment satisfaction.

Anonymous Patient Answer

What is treatment?

This patient is at risk for developing progressive multifocal leukoencephalopathy (PML). He is taking natalizumab, which is on the FDA's black box list of medications that could lead to PML. He tells me he has been taking natalizumab for 6 months, but his blood tests show that his Natalizumab does not reach its therapeutic target. I am not sure how long the blood tests will take to come back. If the test comes back positive for Natalizumab, then he should stop taking the drug, because it is one of the drugs that can cause PML.

Anonymous Patient Answer

What are the signs of multiple sclerosis?

Multiple sclerosis affects individuals differently depending on many factors like age, sex, race, location, and education level. MS patients are most commonly found during their twenties, menopause, and middle ages. There are many symptoms associated with MS such as sensory loss, muscle weakness, numbness, bowel/bladder problems, depression, and worsening fatigue. The debilitating nature of MS makes it difficult for people to live full lives.\n

Anonymous Patient Answer

How serious can multiple sclerosis be?

Patients with a history of psychosis, particularly those who have a history of substance use disorders, need intensified psychiatric evaluation. Patients who experience such psychotic experiences need close monitoring and treatment in order to prevent the development of severe disease.

Anonymous Patient Answer
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