Researchers seek volunteers for self-compassion survey

Oregon State University researchers are seeking participants for an online survey to investigate the relationship of self-compassion on resilience, physical activity, and quality of life for individuals with MS.

Subjects between the ages of 18 and 65 who can communicate in English and have a medical diagnosis of MS are eligible to participate in this study. The survey takes 20 to 30 minutes to complete. Participation in the survey is voluntary. Personal identification information will be removed from the survey data.

Survey answers will help improve understanding of the process of self-compassion and physical activity on improving health-related quality of life for individuals with MS. Results from this study will also help researchers develop effective health interventions to improve wellness and quality of life for people with MS.

To complete the survey, visit http://oregonstate.qualtrics.com/SE/?SID=SV_8ktgzQ9Jki71UEt

If you are interested or have any questions, contact the research team at nerym@onid.oregonstate.edu.

Mom's Story, a Child Learns about MS is available in more formats

Mom's Story can be found on the following sales channels:
Apple -
Kobo -
Oyster -.
Page Foundry -.
Scribd -
Tolino -
Also available on Kindle, Nook,
Available as .Mobi and .epub files from mjnickum@saguarobooks.com

MS Trial Alert: Investigators Nationwide Recruiting People with MS for Phase I Study to Determine Safety of Experimental Antibody in Treating Relapse

Summary: Investigators nationwide are recruiting 30 people with MS for a phase I study to determine the safety and tolerability of rHIgM22, an experimental antibody. Participants may remain on their current therapy throughout the study. The study is enrolling participants experiencing a clinical acute relapse (new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days) and with at least one new, active lesion (damaged area) on MRI scans. The study is funded by Acorda Therapeutics, Inc.
Rationale: Although the body repairs some damage to nerve-insulating myelin that occurs in MS, this repair is insufficient. One strategy under study is to stimulate the body’s own internal repair capabilities. With funding from the Hilton Foundation, NIH, the National MS Society and others, Moses Rodriguez, MD, and colleagues (Mayo Clinic Foundation) identified a human antibody – rHIgM22 – that targets and attaches to myelin-making cells. When given to mice with an experimental MS-like disease, rHIgM22 promotes myelin repair. This antibody was well tolerated in another phase I study (trial NCT01803867, as listed on clinicaltrials.gov) in 55 people with all types of MS. (Abstract #P4.339, Annual Meeting of the American Academy of Neurology 2015)
Eligibility and Details: Men and women between the ages of 18 and 70 with a diagnosis of MS are eligible. The study is enrolling participants with a clinical acute relapse; an MRI will be performed to confirm that there is an active lesion (damaged area). There are detailed exclusion criteria related to laboratory, cardiac, immune and other factors. For more information on these criteria, please use the contact information below.
Participants will remain on their current therapy throughout the study. Upon entering the study with an acute relapse, subjects will receive high-dose oral steroids for five days, a standard treatment for an acute relapse. Following completion of the oral steroids for the acute relapse the subjects will receive either a single dose of rHIgM22 or placebo.
Investigators are testing 2 dose levels. For each dose, 10 participants are being randomly assigned to receive active treatment (rHIgM22) and 5 are being randomly assigned to receive inactive placebo, both via a single intravenous infusion. Blood samples will be collected from participants before and at specified times for up to 48 hours after dosing, so participants must agree to remain in the hospital for that time. Participants are being followed for 180 days after dosing, which includes return visits to the clinic and MRI scans.
The primary outcome of the study is to determine the safety and tolerability of rHIgM22 in people with MS. Adverse events are being monitored throughout the study. The investigators will also evaluate how this experimental treatment is absorbed in the body, and how the immune and nervous systems react to it. Phase I studies are the first of three stages of clinical trials that determine whether an exploratory treatment is safe and beneficial.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Kevin Cronin, Manager Corporate Communications, kcronin@acorda.com, 914-326-5279, or visit the trial’s listing on clinicaltrials.gov to find the site nearest you.
Sites are recruiting in the following cities:
Aurora, CO
Centennial, CO (Denver metro-area)
Dallas, TX
Indianapolis, IN
Long Beach, CA
Rochester, NY
Sacramento, CA
Saint Louis, MO
San Francisco, CA
Seattle, WA
Stanford, CA
Teaneck, NJ (NY metro area)
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
 

Study Shows MS Progresses Faster in Those Who Continue to Smoke

Summary

• A new study involving people with MS who smoked cigarettes suggests that those who continued to smoke after receiving an MS diagnosis were quicker to reach the secondary-progressive phase of MS than those who quit after diagnosis.
• Those who continued to smoke converted to secondary-progressive MS at a median age of 48, while those who quit smoking within the year after MS diagnosis progressed at a median age of 56.
• This adds to evidence that smoking may speed progression of MS, and offers new evidence that quitting smoking after MS diagnosis may slow progression.
• The team (Ryan Ramanujam, PhD, Jan Hillert, MD, PhD, and colleagues at Karolinska University Hospital Solna, Stockholm, Sweden) has published results in JAMA Neurology (Published online September 8, 2015). The full paper is available free of charge.

Background: In most people, MS begins with a relapsing-remitting course with defined attacks of worsening neurologic function, followed by periods of partial or complete recovery. Most people eventually transition to secondary-progressive MS, where the disease begins to progress or worsen more steadily, with or without relapses. The factors that determine if or when a person may transition to secondary-progressive MS are not fully understood. Some studies have found that smoking is related to disease progression, and that MS disability progresses more quickly in smokers, but the impact of quitting after diagnosis had not been thoroughly determined.
The Study: Investigators identified 728 people with MS who smoked at the time of MS diagnosis and were enrolled in the large Genes and Environment in MS Study in Sweden. Of these, 332 were classified as “continuers” who smoked at least one cigarette per day continuously from the year after diagnosis and 118 were considered “quitters,” who had stopped smoking within the year after diagnosis. A group of 278 were “intermittent smokers” but were not included in the final evaluation.
The main focus of the study was to determine how smoking was related to conversion to secondary-progressive MS, which occurred in 216 people. The researchers found that each year of smoking after diagnosis accelerated the time to conversion to secondary-progressive MS by 4.7%. Continuers progressed to secondary-progressive MS faster (at a median age of 48) compared with quitters (age 56).
Results were published in JAMA Neurology (Published online September 08, 2015). The full paper is available free of charge.
Comment: This is an important study that adds to evidence that smoking speeds progression of MS, and offers new evidence that quitting smoking after MS diagnosis may slow progression. In an accompanying editorial, Drs. Myla D. Goldman (University of Virginia, Charlottesville) and Olaf Stüve (University of Texas Southwestern Medical Center at Dallas) comment that this may be the first evidence that quitting smoking can delay conversion to secondary-progressive MS. “Therefore, even after MS diagnosis, smoking is a risk factor worth modifying,” they write.
The National Institutes of Health provides resources to help quit smoking: visit smokefree.gov or call 1-800-QUITNOW (1-800-784-8669).

Out for a time...

For medical reasons, I will be unavailable until mid October.

Case of PML Reported in Person Taking Tecfidera®

In December 2014, important label changes were made to the prescribing information for Tecfidera® (dimethyl fumarate, Biogen Idec) including information regarding an individual who developed PML. Most recently, Biogen has confirmed report of a second case of PML (progressive multifocal leukoencephalopathy, a viral infection of the brain that often leads to death or severe disability) that occurred in a person taking Tecfidera. According to the company, the 64-year-old patient has primary progressive MS and experienced severe and prolonged lymphopenia (decreased white blood cells) during treatment with Tecfidera. Severe and prolonged lymphopenia is a known risk factor for PML and Consideration should be given to interrupting treatment if lymphocyte counts are low for more than six months.  The patient is stable and is not hospitalized. Biogen has reported the case to the U.S. Food and Drug Administration (FDA).

PML is caused by the re-activation of a virus called the JC (John Cunningham) virus, a common virus to which many people have been exposed. PML has emerged in people using other medications, including the MS treatment Tysabri® (natalizumab, Biogen), and the MS treatment Gilenya® (fingolimod, Novartis AG).

It is not possible at this point to determine a person’s risk for developing PML because there have been so few cases in people taking Tecfidera. There have been two reported cases of PML in people with MS among the more than 155,000 individuals who have been treated with Tecfidera to date.

The symptoms of PML are diverse and can be similar to MS symptoms. For this reason, individuals should be alert to any new or worsening symptoms and report them promptly to their MS healthcare provider.  Learn more about the risk factors and symptoms of PML from the web site of The PML Consortium. Individuals who have concerns about this report should discuss it with their MS healthcare providers.

If and when the FDA or Biogen provide additional information or recommendations for people taking Tecfidera or other MS medications, the National MS Society will share it as soon as possible.

Recent Update to Gilenya Prescribing Information

A recent warning and precaution has been added to the prescribing information for Gilenya® (fingolimod, Novartis AG), an oral disease-modifying therapy for relapsing forms of multiple sclerosis. The warning adds Cryptococcal fungal infections to the list of possible infections for which people taking Gilenya are at increased risk. Anyone receiving this or other medications that can compromise immune system function should promptly report any new or worsening symptoms – both MS-like symptoms and other symptoms – to their neurologist.
The updated prescribing information approved by the U.S. Food and Drug Administration states that there have been cases of cryptococcal infections, including cryptococcal meningitis, reported in people taking Gilenya. Individuals and their healthcare providers should be alert to symptoms and signs that could indicate cryptococcal meningitis. This rare condition can be managed if it is diagnosed and treated promptly.
Cryptococcus is a type of fungus that is commonly found in the soil throughout the world. The fungus becomes airborne and people may breathe in microscopic amounts. Most people never get sick from breathing the fungus; cryptococcus typically infects people who have compromised immune system function – which can occur from illness, or due to the effect of some medications, including some medications that are prescribed to treat MS.
Infection with cryptococcus is uncommon, but it can be very serious and even lead to death if untreated. It is important to recognize the infection early and treat it promptly. The usual sites for cryptococcal infections are the lungs and the central nervous system (brain and spinal cord).
 
Symptoms of a lung infection may include:
• cough
• chest discomfort
• shortness of breath
• low grade fever
• weight loss
• a general sense of feeling unwell
Central nervous system infections may produce numerous symptoms including:
• headache
• confusion
• stiff neck
• light sensitivity
• mild fever
• nausea and vomiting
• vision change
• unsteady walking
• change in speech
• seizures
• abnormal muscle movements
The increased risk of many types of infection is also pertinent to people with MS who are receiving other powerful immune modifying or suppressing therapies. Therefore, it is important when receiving medications that can compromise immune system function to promptly report any new or worsening symptoms – both MS-like symptoms and other symptoms, such as those mentioned above – to your neurologist. It is also important to speak to with your doctor before making any changes to your medications.

Download the updated prescribing information (.pdf)
Download the updated medication guide for patients (.pdf)