Sensory problems, including restless leg syndrome (RLS), numbness and weakness, are the first sign of multiple sclerosis (MS). Sensory problems can occur in 20 to 50 percent of individuals with multiple sclerosis with a condition known as paresthesia. The condition can be caused by prolonged sitting or standing or remaining in a certain position for a long period of time.
Restless leg syndrome is a condition that makes the legs feel tingling when they are at rest and creates an overwhelming sensation to move them. Studies have shown that individuals with MS are three times more likely to experience restless leg syndrome compared to the general population. Cervical cord damage plays a large role in the development of RLS and can occur more in those with multiple sclerosis.
Feelings and sensations of restless leg syndrome include crawling underneath the skin, tingling, burning or creeping. Symptoms may be relieved with movement of the legs, but this relief is temporary. Furthermore, it’s impossible to keep your legs moving constantly, which makes the hours during sleep the most difficult. Many individuals suffer from sleep deprivation when they have RLS.
Numbness, as well, is a common sensory problem in those with multiple sclerosis. When the nerve’s transmitted sensations are not conducted properly it causes lack of sensation in the affected area. Numbness is considered more of an annoyance than disabling and usually occurs in small locations for those with MS. There are cases, though, where numbness can affect a person’s ability to function.
Weakness in multiple sclerosis can be caused two different ways: It can result from spasms or fatigue or it can result from damaged nerves. The first cause of weakness can result in loss of strength or loss of control of extremities. Due to the second cause of weakness signals may become disrupted and not reach the extremities.
MS Society partners in CCSVI clinical trial
September 28, 2012 – Halifax –
The Multiple Sclerosis Society of Canada welcomes the federal government’s announcement that the Phase I/II clinical trial for chronic cerebrospinal venous insufficiency (CCSVI) has received the necessary medical and ethical approvals required to proceed. The national MS clinical trial is a collaborative initiative between the Government of Canada, provinces and territories, and the MS Society. In September 2010, the MS Society committed funding towards the financial cost of a clinical trial to support a pan-Canadian interventional clinical trial on CCSVI and MS. The clinical trial will be led by Dr. Anthony Traboulsee of the UBC Hospital MS Clinic and his collaborators. Dr. Traboulsee and his team received ethics approvals from institutions in British Columbia and Quebec to study the safety of venous angioplasty and gather information on patient outcomes. Ethics approval is still ongoing in Manitoba. “We are excited that the clinical trial is underway and that MS is being recognized as a top-priority health issue that is meaningful to Canadians,” says Yves Savoie, president and CEO of the MS Society of Canada. “The research of Dr. Traboulsee and his team will provide significant insights to those living with MS and provide answers to the many questions that exist around CCSVI and MS.” According to the announcement, participant recruitment for the trials will start by November 1, 2012. “When it comes to my health, I have a lot of questions and I want all the information possible – I am hopeful that this clinical trial will help me answer some of the questions my family and I have about CCSVI,” says Theresa Denham who has been diagnosed with MS for 22 years. -30- For more information about the seven CCSVI studies funded by the MS Society and the National Multiple Sclerosis Society please visit ccsvi.ca. About multiple sclerosis and the Multiple Sclerosis Society of Canada Multiple sclerosis is a chronic, often disabling disease of the brain and spinal cord. It is the most common neurological disease of young adults in Canada. Most people with MS are diagnosed between the ages of 15 and 40, and the unpredictable effects of MS last for the rest of their lives. The MS Society provides services to people with MS and their families and funds research to find the cause and cure for this disease. Please visit mssociety.ca or call 1-800-268-7582 to make a donation or for more information.
A chemical that can be used as a food additive, caused serious skin infections after people sat on sofas treated with it and was approved as a psoriasis treatment in Germany 15 years ago, may prove to be a viable treatment option for people with the relapsing-remitting form of multiple sclerosis (MS).
Dimethyl fumarate - also known so far as BG-12 - could be another weapon in a neurologist's arsenal to treat the disease, if the drug is approved. Based on the results of two large studies published in the New England Journal of Medicine, experts believe this is likely.
More than 2 million people around the world live with MS, a disease where the body's immune system attacks the patient's central nervous system and destroys the myelin, or sheath, protecting nerve cells. Most people are diagnosed between the ages of 20 and 50, and more women than men are affected, according to the National MS Society. As the disease progresses, it can become quite debilitating, leading to numbness and difficulty walking and seeing among many other symptoms.
"Relapsing MS is a disease that we have treatments for, but they're really on two ends of the spectrum," says Dr. Robert Fox, a neurologist at the Mellen Center for MS at the Cleveland Clinic. "We have injection treatments that have modest efficacy. They reduce relapses by about 30%.
"And we have very effective therapies, but they are infusion therapies and they have risk - risks of a brain infection - that may be fatal," Fox says. "This new treatment offers the opportunity for sort of the best of both worlds, in that it has very good efficacy, but it's in the form of a pill and appears to have much reduced risk than other therapies."
Fox, who is the lead author of one of the studies, says both studies published Wednesday were designed in the same way so their results could be examined together. Both were large trials involving more than 1,400 patients in many countries and both compared BG-12 to a placebo - a common scenario when seeking drug approval.
He says both studies showed BG-12 reduced the number of relapses, reduced the number of lesions or scars on the brain and progression of disability and was more effective than standard injectable MS drugs.
Both studies found BG-12 was well tolerated and seems to be safe. They looked at taking the pill two and three times day. Fox says between the two studies, taking the pill three times a day wasn't significantly better than twice a day, which is why the FDA drug approval application only refers to twice daily dosing.
Timothy Coetzee, chief medical research officer for the National MS Society, says the study results look very promising. He says it's a "good news story for people who live with MS" because the pill has been shown to be effective in reducing the number of relapses. Coetzee says it's too early to say BG-12 is superior to other MS drugs in pill forms, as studies haven't been done yet.
Based on these results of these two studies, Fox and Coetzee believe the FDA will approve the drug. Only after that happens will we know what name manufacturer Biogen Idec will sell BG-12 or dimethyl fumarate under, as well as its price. The FDA has until December 28 to make a decision.
If this happens, BG-12 would be the third MS drug in pill form approved by the FDA. Just last week, the agency approved another MS drug in pill called Aubagio. It too was shown to be effective in reducing the number of relapses, slowing down disease progression and reducing the number of brain lesions. The first pill, Gilenya, was approved two years ago.
Like any drug, these new MS drugs in pill form have their pros and cons. Each of these pills "targets a different part of the immune system in a very specific manner," says Coetzee, which may influence what a patient may be prescribed and how they react to each drug.
Side effects also are a consideration. Since people as young as 20 could be diagnosed with this disease that affects 2.1 million people worldwide, women who want to get pregnant or who are pregnant would not be a candidate for Aubagio because it could cause severe birth defects.
Patients taking Gilenya have to be monitored for the possibility of their heart rate slowing down. Earlier this year, health agencies in the United States and Europe were reviewing safety concerns after 11 deaths were linked to patients taking Gilenya.
BG-12 is not without side effects. The two-year clinical trials showed common side effects including skin flushing and some nausea, vomiting and diarrhea - usually in the first month. After that, Fox says, patients did quite well. What hasn't been seen in patients so far is an increased risk of infections or cancer with this drug, says Fox.
And then there are still the older injectable and infusion drugs that may still work very well for those patients taking them. Coetzee believes some patients may want to wait until these drugs stop being effective and then shift to another option.
Cost could be another
issue. Aubagio costs about $45,000 per year; Gilenya about $48,000.
Twenty-five years ago, options were few for MS patients. Now doctors and patients have nine options and perhaps 10 by the end of the year. "That's really good news, if you're diagnosed with the relapsing forms of MS," says Coetzee. But he notes that those with more progressive forms of the disease are still awaiting treatment choices.
Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in patients with relapsing–remitting multiple sclerosis.
We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of 1106 patients with relapsing–remitting multiple sclerosis were randomly assigned in a 1:1 ratio to receive oral laquinimod at a dose of 0.6 mg once daily or placebo for 24 months. The primary end point was the annualized relapse rate during the 24-month period. Secondary end points included confirmed disability progression (defined as an increase in the score on the Expanded Disability Status Scale that was sustained for at least 3 months) and the cumulative number of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted magnetic resonance imaging.
Treatment with laquinimod as compared with placebo was associated with a modest reduction in the mean (±SE) annualized relapse rate (0.30±0.02 vs. 0.39±0.03, P=0.002) and with a reduction in the risk of confirmed disability progression (11.1% vs. 15.7%; hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; P=0.01). The mean cumulative numbers of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted images were lower for patients receiving laquinimod than for those receiving placebo (1.33±0.14 vs. 2.12±0.22 and 5.03±0.08 vs. 7.14±0.07, respectively; P<0.001 for both comparisons). Transient elevations in alanine aminotransferase levels to greater than three times the upper limit of the normal range were observed in 24 patients receiving laquinimod (5%) and 8 receiving placebo (2%).
In this phase 3 study, oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing–remitting multiple sclerosis.
This Blog is intended to provide news and information to people living with MS, their families, caregivers, medical professionals and other stakeholders. Information/opinions contained in this blog are obtained from sources believed to be reliable, but their accuracy cannot be guaranteed. This blogger does not approve, endorse or recommend specific products or services and respects an individual’s right to make their own health management decisions. However, we can provide information to assist people in their decision process. For specific, personalized information, please consult your physician or other health care professional.