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Thursday, December 11, 2014

Clinical Focus in MS: Novel Approaches to Progressive Disease

Although the drug development pipeline still contains numerous products intended for patients with relapsing-remitting multiple sclerosis (RRMS), the consensus among clinicians is that relapses can be effectively squelched in nearly all RRMS patients with the dozen or so currently approved therapies.

Patients now have a choice between injectables and oral drugs, and within the injectable class there is a range of dosing intervals and delivery types -- expanded recently with the approval of alemtuzumab (Lemtrada) that requires just two brief courses of therapy a year apart.
The more pressing clinical need now, researchers told MedPage Today, is for treatments that stop or reverse the progressive forms of MS. This has been a tougher nut to crack because the mechanisms underlying progressive MS are less well understood than the acute demyelinating attacks that characterize RRMS. A particularly important aspect that remains mysterious is the switch that occurs in many patients from RRMS to the secondary progressive form or SPMS.
Currently the sole FDA-approved treatment for SPMS is the chemotherapeutic agent mitoxantrone, which has only been tested in two small trials of questionable design that showed relatively modest efficacy. The drug also has significant toxicities that earned a lengthy boxed warning on its label.
But that doesn't mean MS researchers haven't made any progress -- in fact, enough knowledge about progressive MS has accumulated that rational approaches to therapy are now in clinical development. The following is a rundown, aided by Jeffrey Cohen, MD, who spoke at length recently with MedPage Today. Cohen is director of the experimental therapeutics program in the Cleveland Clinic's Mellen Center for Multiple Sclerosis.
He summarized the field's current status in progressive MS this way: "There are now a lot of candidate approaches being considered and we're finally starting to test them."
Jumpstarting Oligodendrocyte Activity
One firmly established feature of advanced MS is that the physical disability results from destruction of nerve axons following demyelination -- the process that defines MS in all its forms, stripping away the protective myelin sheaths from axons.

For the Full Story Click http://www.medpagetoday.com/Neurology/MultipleSclerosis/48725  

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Wednesday, December 10, 2014

Sailboat crew wants to sink perceptions about abilities of people with MS

December 9, 2014
FORT LAUDERDALE, Fla. — A 67-foot sailboat is making a first-of-its-kind journey around the world: using crew members diagnosed with multiple sclerosis to navigate through 33,000 nautical miles.
The bright-orange vessel stopped at Bahia Mar in Fort Lauderdale recently after sailing down the eastern seaboard with nine crew members aboard.


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Madeleine Stowe Continues US Multiple Sclerosis Tour to Share Her Family Story

Madeleine StoweDecember 9, 2014
Actress and star of the ABC show “Revenge”, Madeleine Stowe, recently shared her personal story of living in a family with someone who suffers from  multiple sclerosis (MS). Her father lived for many years with the disease. The actress has decided to help not only MS patients but also other families like her own who live and struggle with MS by sharing her story on a national tour recently announced by the National Multiple Sclerosis Society. In addition, Stowe is also involved in the Lights, Camera, Take Action on MS campaign, which is being organized by biotech company Genzyme.
Stowe has shown herself to be quite a different person in real life from the character she plays in “Revenge,” Victoria Grayson. During her tour this winter, she is going to share the story of growing up in a family afflicted by MS, which will include meetings with MS patients, neurologists, and lifestyle experts, who will also share their experiences and ways of dealing with the disease.
“My mother had told me that they thought he had it before she married him and it went into remission,” said Stowe in an interview by Marc Malkin to E!. “Then when I was about three or four years old, they thought it was coming back. At five years old, I remember him walking on crutches. At six years old, I think he started to rely more and more on a wheelchair.”

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3 Times a Week Dose Copaxone for Relapsing MS Receives Positive Outcome in Europe

Israel-based biopharmaceutical company Teva Pharmaceutical Industries Ltd.announced last week that its thrice-weekly COPAXONE® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe that had participated in the procedure. The company is anticipating the granting of national marketing authorizations for Copaxone® very soon.
The Reference Member State’s Positive Assessment Report was based on the impressive findings from Teva’s Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, which involved over 1,400 patients. Results revealed patients dosed three times a week with Copaxone 40 mg/mL experienced significantly reduced relapse rates at 12 months, and a favorable safety and tolerability profile.
Continue reading

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New study investigates ways to help people with MS respond to sudden balance challenge

December 10, 2014

Many people with multiple sclerosis (MS) have trouble with balance and a fear of falling, which can have severe negative effects on their quality of life by keeping them away from social events, regular exercise and community activities. And, if they do get out, the fatigue and anxiety of walking can be very taxing.

Now a new pilot study at the University of Massachusetts Amherst, funded by a one-year, $39,000 grant from the National Multiple Sclerosis Society, will investigate how sensation in the feet while standing relates to balance ability and whether vibrating insoles might aid walking and improve balance.

Research assistant professor Stephanie Jones and professor Richard van Emmerik in the department of kinesiology at UMass Amherst, will test sensation in two areas on the soles of the feet of people with and without MS as they stand and sit and use the data to determine how this relates to their balance ability.

The researchers believe this study will be the first ever conducted with people both sitting and standing to determine whether thresholds differ with weight bearing. As Jones explains, traditionally tests are performed only with subjects lying down.

For the pilot project that is to involve a total of 30 subjects, the researchers are recruiting people with and without MS between 21 and 65 years old who are ambulatory and able to stand unassisted. They will have baseline function tested including a 25-foot walk, muscle strength testing, tests of pressure and vibration sensation of the skin, standing balance and posture evaluation.

Jones says, "There is a lot of evidence that the somatosensory system, that is the skin's sensation and body awareness or proprioception, is affected in people with MS, who often report peripheral sensory loss, for example."

In the study, the kinesiology researchers will build upon recent technology that can improve skin sensation by applying a vibration to the soles of the feet at a level below the detection threshold. Such small, irregular vibrations have been shown to restore some of the lost sensation and improve balance in people with sensory loss in their feet because of diabetes or stroke, the researchers note.

"This method exploits the phenomenon of stochastic resonance of the nervous system," Jones explains. "It applies a kind of 'noise' that can enhance a person's skin sensation."

For these experiments, small devices called "tactors" placed in the subject's shoes will produce the slight vibrations. Each subject will be tested to find the most sensitive parts of their sole. With tactors in place, each subject will take a blinded test, that is without knowing whether the vibration is on or off, during five different postural conditions. Then after a five-minute wait, the five conditions will be tested again to see if there is any carryover effect of the vibration.
The final phase of the UMass Amherst kinesiology study will test the ability of tactors to help people with MS as they detect and respond to a sudden balance challenge. Jones explains, "Because their nervous system is compromised, people with MS show a much greater delay in detecting and responding to unexpected balance disturbances. One of our goals is to see if we can enhance the ability to detect and respond to a sudden challenge and in doing so, improve balance. In this case, the challenge will be a shift of the surface underfoot, a bit like what you get when you step onto an escalator."

Subjects will stand on a platform that will suddenly move about 3 inches (8 cm). "This is not enough to cause most people to fall but it's enough to see the muscles fire that are needed to keep you upright. We hope tactors might reduce that delay so that these muscles will fire sooner and the person would be less de-stabilized with them in place," Jones notes.

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CWRU nursing school develops how-to exercise pamphlet for people with MS

Contact: Susan Griffith
Case Western Reserve University

Fatigue and pain, along with other symptoms, prevent many people with multiple sclerosis (MS) from exercising. But a new how-to guide for a home-based exercise program, tested by researchers at Case Western Reserve University's nursing school and the Lerner Research Institute at the Cleveland Clinic, offers a way for people with MS to stay more physically active.

The researchers developed a 24-week exercise program based on a series of pamphlets with varying levels of difficulty. The program helps inactive individuals start at a lower, shorter level of activity and gradually build to longer, more difficult exercise routines.

"The printed pamphlets have shown promise in helping people with multiple sclerosis engage in exercise and offset the disabling effects of multiple sclerosis," said Matthew Plow, assistant professor at Case Western Reserve's Frances Payne Bolton School of Nursing and an exercise trainer for people with MS.
MS is thought to be caused by an abnormal immune response that attacks the central nervous system. An estimated 2.3 million people worldwide suffer from MS symptoms, which can vary from person to person, according to the National Multiple Sclerosis Society.

Along with pain and fatigue, other symptoms of MS include numbness and tingling, weakness, dizziness, feelings of stiffness, vision problems and walking difficulties.

But physical activity (PA) may help counter the debilitating physical symptoms and delay cognitive impairment associated with the autoimmune disease.

Plow is lead investigator on a study that tested a home-based exercise program to help people maintain their ability to balance, walk and use their hands and arms.

A series of pamphlets is designed to meet the individual's starting exercise level and unique symptom profile. The program was adapted from a distance-learning intervention designed by one of the study's researchers, Bess Marcus, from the Department of Family and Preventative Medicine at the University of California at San Diego.

Marcus' work focused on increasing the motivation to exercise and taking people through the five stages of readiness to exercise and change behavior: pre-contemplation, contemplation, preparation, action and maintenance of an exercise program.

Researchers recruited 30 women with doctor-confirmed diagnoses of relapsing-remitting MS to test the new exercise program.

The women suffered similar symptoms of fatigue and pain and also lacked the time or motivation to use a gym or take exercise classes. Each received instructions for exercise to do at home or in the neighborhood to increase their physical activity.

Participants started with the pamphlet that matched their PA levels. The step-by-step instructions helped participants establish an exercise routine that consists of aerobics balance exercises and strength training.
Researchers called the participants every three weeks with questions about the women's PA habits and barriers that may have prevented them from exercising. The participants also were interviewed and underwent a physical assessment at 24 weeks to track changes.

Results from the pilot study indicate the program shows promise in improving physical function and reducing symptom severity.

According to Plow, the program was well received--even by some of the women who had shied away from workout facilities.


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Tuesday, December 9, 2014

Abnormal mental states in multiple sclerosis

Dr Hugh Rickards, consultant in neuropsychiatry, Queen Elizabeth Psychiatric Hospital, Birmingham
Way Ahead 2003;7(1):6-7

"The mind is what the brain does" - Prof. Steven Pinker: How the mind works.
MS is primarily a disease of the brain. As this is where mental functions are controlled, it isn't surprising that changes in mental status are common in people with MS (PWMS).
However, mental disorders in MS are frequently overlooked for a number of reasons:
  • Changes in mental state are considered to be solely a 'reaction' to having a chronic illness
  • Many mental health services have retracted so they only treat 'functional' mental illnesses
  • The relatively few neurologists in the UK often restrict themselves to diagnostic issues and managing physical symptoms
  • Understanding symptoms of mental disorder is a complex process, often touching on personal and family issues. It can be easier to stick to the physical and practical aspects of care.
The burden of responsibility for mental illness in MS usually falls on relatives, carers and MS specialist nurses, who don't always feel adequately skilled to advise. This burden is heavy and may contribute to reduced quality of life in MS.
Practitioners need a number of skills to manage mental disorder in MS, including knowing how MS affects the brain, understanding the effects of prescribed and non-prescribed drugs on mental function and being able to recognise major mental disorders, such as depression, psychosis and cognitive impairment. Additional skills include understanding psychodynamic theory and "family systems" theory.

Depression in MS

Depression is a very common mental illness in MS. Around half of all PWMS will have clinical depression at some time, around three times the incidence in the general population. Depression in MS can sometimes be difficult to diagnose as many symptoms, such as fatigue, weight loss and lethargy, may occur in both conditions. Important clues in the diagnosis of depression include: pervasive low mood, sometimes with diurnal variation - often the mood is particularly bad in the morning; reduction in physical function that is disproportionate to their level of physical disability - level of physical disability does not correlate well with the risk of getting depression; and suicidal ideation. Suicidal ideas are quite common in PWMS who attend clinics, occurring in 25% at any one time. One study showed around 3% of PWMS will take their own lives, especially socially isolated young men with MS.
Transient low mood is normal in the period immediately after diagnosis and is known as adjustment disorder. Various common medications in MS, such as steroids, baclofen, dantrolene and interferon can cause changes in mood in either direction. Physical conditions, such as anaemia, vitamin deficiencies and thyroid disease can present with depression and need to be excluded.
Treating depression in MS is often rewarding and drugs in the Specific Serotonin Reuptake Inhibitor (SSRI) group are probably safest. Common side effects, usually transient, include nausea, sexual dysfunction and gastrointestinal disturbance. Withdrawal from these drugs should be gradual, especially with paroxetine (Seroxat).
Mania is relatively rare and, where it occurs, one should consider whether prescribed or non-prescribed drugs have been the trigger.

Paroxysmal emotional states

Paroxysmal emotional states are transient changes in behaviour or emotion, which resolve quickly. These are divided into pathological laughing and crying and emotional lability.
Pathological laughing and crying can occur in up to 10% of PWMS. The response can be to random stimuli and not related to how the person is feeling. Such laughing or crying may be short-lived (lasting only a few seconds) and is particularly seen in people with chronic MS with cognitive impairment. Pathological crying can be mistaken for depression but the mood is usually not pervasively low. Where it causes distress or disability treatment may be with amitryptilline, l-dopa or amantadine.
Emotional lability is characterised by an excessive emotional response to a minor stimulus, eg excessive emotional responses to soap operas on TV. Again the response is transient and has been described as 'an April shower'. Effective treatment has been described with carbamazepine and SSRIs.

Psychosis in MS

Psychotic symptoms - delusions, hallucinations and thought disorder - are uncommon in MS but extremely distressing. This may result in family breakdown and nursing home placement. Symptoms are similar to those seen in 'functional' psychoses such as schizophrenia, although visual hallucinations are more prominent and the mean age of onset (36 years) is later.
If a PWMS becomes psychotic (especially if there is acute onset) it is important to rule out physical triggers such as chest and urinary tract infections and metabolic disturbances. Steroids, baclofen and dantrolene have all been reported to trigger psychosis in people with MS so a close review of the treatment history is vital. People with severe depression may develop psychotic symptoms congruent with their mood - for instance delusions of poverty or guilt - and here treatment should be aimed at the depression. Finally, psychotic symptoms in MS may be the presenting feature of dementia.
People with MS are particularly sensitive to neuroleptic (anti-psychotic) medications. Rigidity and bradykinesia are commonly encountered even at low doses of conventional neuroleptics such as haloperidol. Therefore, atypical antipsychotics (quetiapine or olanzapine) should be first line therapy in this situation. The few studies about the prognosis of psychosis in MS suggest that treatment response is fair.

Cognitive changes

Many PWMS experience significant changes in cognitive function over time. Around 40% of PWMS in the community have some cognitive impairment. Typical problems include reduced speed of processing, reduced attention span and problems with executive function. Such problems may be the source of considerable disability but may not register on standard tests, such as the Folstein Mini Mental Status Examination or MMSE, or at clinical interview as verbal skills may be unaffected. Occupational therapy assessment at home is one of the best ways of detecting impairments in executive function. Specific tests that can reveal executive dysfunction include the Addenbrookes Cognitive Examination (ACE), the Frontal Assessment Battery (a short, sensitive, 'bedside' test) and the Behavioural Assessment of Dysexecutive Syndrome (BADS).


Mental status changes are extremely common in MS and are relatively neglected. They need thorough assessment with particular attention given to mood changes, cognition and perception. Many treatment or management strategies are effective.

There is a real danger that people with MS and mental illness will be excluded from services and it is vital that health professionals in neurology, psychiatry and rehabilitation work together to prevent this.


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Through Laughter and Tears Comes First-Ever Documentary about Life with PseudoBulbar Affect (PBA)

--Award-Winning Filmmakers Capture Untold Story of Little-Known Neurologic Condition That Affects Nearly 2 Million Americans--

Press ReleaseAvanir Pharmaceuticals, Inc

LISO VIEJO, Calif., Dec. 9, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (AVNR) today announced the initiation of production of The PBA Film Project (working title), the first-ever documentary to provide an intimate look at real people living with a little-known neurologic condition called PseudoBulbar Affect (PBA). The award-winning filmmaker team of The PBA Film Project includes co-directors Doug Blush and Lisa Klein (Of Two Minds) and producer Julian Cautherley (The Crash Reel).

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