FW: eMS News: Laquinimod: A Potential New Oral Treatment; A Wii Problem; Clinical Trials

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Anyone want to bombard these people with emails about how thousands of people are already taking a very good oral treatment for MS? I think I may have written one too many emails to them already and they probably think I`m a crazy woman! Bev

bevkean777@...From: jmcconkey@...Subject: eMS News: Laquinimod: A Potential New Oral Treatment; A Wii Problem; Clinical TrialsDate: Wed, 19 Jan 2011 14:55:23 -0600

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In this edition of eMS News January 19, 2011

Laquinimod, a Potential New Oral Treatment Caregiver's Month: Book reveiw and recommendations Novartis Primary Progressive, Ono, Elan, and Copaxone plus Oral Estriol

We hear from you! In this Edition: A Wii Problem

Events and Seminars

Resources

Laquinimod, a Potential New Oral Treatment, Shows PromiseBreaking News

Dr. Tim Vollmer, Medical Director of the Rocky Mountain MS Center A new experimental oral multiple sclerosis drug, laquinimod, has met its primary endpoint in a two-year phase III study named ALLEGRO. Initial results from the study showed laquinimod, a once-daily oral drug, met primary endpoint of reducing annualized relapse rate. In addition it significantly slowed progression of disability and showed a favorable safety and tolerability profile.Initial results from the study demonstrated that relapsing-remitting multiple sclerosis (MS) patients treated with 0.6 mg daily oral laquinimod experienced a statistically significant reduction in annualized relapse rate compared to placebo. Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved. The ALLEGRO study compared oral laquinimod with placebo in patients with relapsing-remitting MS. The study was conducted at 139 sites in 24 countries and enrolled 1106 MS patients. Laquinimod was safe and well tolerated in the ALLEGRO study. The overall frequencies of adverse events and overall incidence of infections were comparable to those seen with placebo. No deaths were reported among those taking laquinimod. The reduction in the progression of disability may be explained by laquinimod’s unique mechanism of action that seems to include neuroprotective properties. Additional analyses of the ALLEGRO study data are ongoing, and detailed results will be submitted for presentation at a leading scientific conference during the first half of 2011.About LaquinimodLaquinimod is a once-daily, oral immunomodulatory compound being developed as a disease-modifying treatment for MS. Laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2009. In addition to the ongoing MS clinical studies, laquinimod is currently in Phase II development for Crohn's disease and Lupus, and is being studied in other autoimmune diseases. The global Phase III clinical development program evaluating oral laquinimod in MS consists of two pivotal studies, ALLEGRO and BRAVO:The first clinical study, ALLEGRO, was a two-year multi-national, multi-center randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of laquinimod in MS patients. The study was conducted at 139 sites in 24 countries and enrolled 1,106 MS patients. Patients were randomized to receive a once-daily oral dose of 0.6 mg laquinimod or matching placebo. The primary outcome measure was the number of confirmed relapses; secondary measures included confirmed disability progression and changes in MRI active lesions. Patients who completed the ALLEGRO study are offered to join an open-label extension phase, in which they will be treated with laquinimod 0.6mg daily until the drug is commercially available.The second clinical study, BRAVO, is a two-year, multi-national, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to compare the safety, efficacy and tolerability of a once-daily oral dose of 0.6 mg laquinimod over placebo and to perform a comparative risk-benefit assessment between laquinimod and interferon beta-1a. Enrollment of 1,332 patients at 154 sites in the U.S, Europe, Israel and South Africa was completed in June 2009. BRAVO study results are expected in the third quarter of 2011.

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Caregiver's Month Book Review!

Living Well with MS

By Dillback

Fighting Fatigue in Multiple Sclerosis: Practical Ways to Create New Habits and Increase Your Energy. A. Lowenstein. New York: DemosHealth, 2010. 216 pp.Fatigue has repeatedly been reported as one of the most common and disabling symptoms of multiple sclerosis. Findings regarding the percentage of persons who experience MS-related fatigue vary, with 83% of participants in one study claiming fatigue as a current symptom. MS-related fatigue can be both physical and cognitive in nature, and its causes are multifactorial. Energy conservation strategies have been shown through research to have a positive effect on individuals trying to manage this disabling symptom. In "Fighting Fatigue in Multiple Sclerosis: Practical Ways to Create New Habits and Increase Your Energy," A. Lowenstein, occupational therapist, provides practical strategies aimed at combatting the fatigue often associated with multiple sclerosis. Occupational therapists are health care professionals who are skilled at identifying what may be preventing successful participation in activity, and identifying solutions. This book, formatted much like a workbook, starts with teaching it’s readers how to begin to think like an occupational therapist by identifying energy consuming activities, habits, and routines. This identification is the first step in determining how certain activities contribute to fatigue so that the reader can then start to make active changes in order to conserve energy. Strategies reviewed include prioritizing; ways to change oneself, the activity, or the environment in order to be more efficient with energy (including practical ways for changing common activities using tools and simple environmental modifications); the importance of diet and exercise; the importance of restoration, and the importance of a balanced lifestyle. The book ends with a chapter on goal setting. The aim? To help the information stick and commit the reader to change.This book is for anyone experiencing MS-related fatigue who find themselves getting through the must-dos with no energy left for the fun, meaningful activities of life. The concepts contained within the book have been utilized for a number of years in combating MS-related fatigue, and are presented in a way that are easy to understand and immediately applicable to daily life.

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Novartis Primary Progressive, Ono, Elan, and Copaxone plus Oral EstriolClinical Trials

The following studies are limited to people who can travel to the Rocky Mountain MS Center at Anschutz Medical Campus in Aurora, CO.

Novartis Primary Progressive: A clinical research study of an oral investigational medication for primary progressive MS (PPMS). This study will evaluate whether the investigational medication is safe and effective in slowing disease progression associated with PPMS. For more information, click HERE.

Ono: This study is evaluating an investigational, oral medication for RRMS. The study consists of a 10 study visits over the course of up to an 8 month study period. For more information, click HERE.

Elan: To assess whether an experimental drug, called ELND002, is safe and well tolerated for use in patients with relapsing remitting or secondary progressive multiple sclerosis (MS). For more information, click HERE.

Copaxone plus Oral Estriol: The Rocky Mountain MS Center at Anschutz Medical Campus is looking for women with relapsing-remitting MS for a 24-month study to see if there are fewer relapses with the treatment of Copaxone injections plus oral estriol as compared to the treatment of Copaxone injections plus oral placebo. For more information, click HERE.

If you would like to see a more complete list of clinical trials occurring at the Rocky Mountain MS Center at Anschutz Medical Campus, please click HERE.For information on various clinical trials throughout the United States, please visit

www.clinicaltrials.gov

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We hear from you!* Share your thoughts

A BIG Wii PROBLEM, by LeSueurOne of the problems sometimes caused by multiple sclerosis is impaired thinking. However, how do you know whether any diminished capacity is caused by MS rather than natural aging? When I was growing up, an uncle told me that when men got old, brain cells (which look like hair) start growing out of your ears. I was always skeptical, but now I think he might have been right. I figure I have trimmed over a foot of brain cells from my ears over the past decade and that would explain a lot.

At what age do we reach our mental peak? When does everything begin to head South? I can only speak for myself, but I know that at age 16 I pretty much knew everything. However, a more realistic self-assessment is that my IQ peaked around age 3 or 4.

I became worried recently because of an experience I had with our Wii. I consider myself technologically adept. I can program the DVR, play several kinds of Solitaire on my laptop, and figure out how to use our cell phones without even reading the instructions. I even sent four text messages this year. But I have had a big problem with our Wii. I wouldn't even have one except my neurologist suggested that playing bowling, tennis and baseball on a Wii would be a fun way to keep my arms strong and improve my coordination. I always follow my doctor's orders, so we ordered the Wii. I may even deduct it as a medical expense on my taxes.

We installed it using our upstairs television but soon decided that it would be better in the basement. So I unhooked it, took all the components downstairs and tried to install it just as I had upstairs. Unfortunately, after several hours of trying various fixes, I couldn't get it to work. I gave up, knowing I would have to consult an expert - my 13-year-old grandson, . The next time he was over, I asked him to look at what I had done. We went to the basement together. He walked over to the game console, reached for the cord in the back and plugged it into the outlet. Now everything worked! This was very embarrassing.

"You mean I forgot to plug it in?" I asked. nodded. I explained to him the importance of keeping this between him and me. I didn't want my reputation ruined. He explained to me the importance of a $20 bill to him and we soon reached an agreement.

Six months later, I went to the basement to use the Wii and discovered the game controllers weren't working. This is the first time that had happened but I assumed they just needed charging. I looked around but I couldn't see anything that looked like a Wii charger, so I called to get some help. He wasn't home from school yet, so I asked my daughter what she knew about charging the controllers. She said "I don't know. Don't they just use batteries?"

Batteries! I hadn't even thought of that. I looked at the bottom of the controllers and sure enough, there was a compartment with two AA batteries. I replaced them and to my embarrassment, the controllers worked. I was going to explain to my daughter the importance of keeping secrets between her and me so my reputation would not be ruined, when she said "You've had a bad experience getting this Wii to work, haven't you? told me about how you forgot to plug it in earlier this year." I decided that I would have to ask for my money back.The next time I saw my neurologist, I asked him if there was anything I could do to maintain my cognitive abilities. He gave me some exercises and suggestions but emphasized that I needed to actually do them, rather than just thinking about it. He challenged me to do something right when I got home. I accepted his challenge, and when I got home I took my first steps to maintaining my brainpower. I walked into the bathroom, opened a drawer, picked up the nose and hair clipper and threw it in the trash.

You can never have too many brain cells. LeSueur lives in Littleton, Colorado with his wife . He bowled a 168 this week.

*All comments included in "Share your thoughts" are the personal opinions of eMS News readers and do not represent those held by the Rocky Mountain MS Center.

Have something to share? We'd love to hear from you! Send your comments to ita McConkeyor call (303) 788-4030 X 102

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Events and Educational Seminars To see our full calendar of events, please click HERE or go to www.mscenter.org.

MS 101 for the Newly DiagnosedJan 31th, Feb 21th, March 14thJoin Pat Kennedy, NP, and Pat Daily, LCSW, for an informal discussion of issues important to people newly diagnosed with multiple sclerosis. Family members and friends are also welcome. There is no charge, but registration is required and class size is limited. Call 303-788-4030 X 102 or email ita McConkey.

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Resources

eMS News Archives: Read previous editions of eMS News!

InforMS Archives: Read previous editions of InforMS!

NARCOMS is an active national registry of over 34,000 individuals with MS. Help spread the word by telling others about this important project. To register, please click HERE.

KADEP, our specialized adult day program, offers clients over 70 recreational and therapeutic activities weekly. Meet participants and get daily updates at the KADEP blog.The Rocky Mountain MS Center Tissue Bank is actively seeking donors - both people with MS and those without. Help researchers as they work toward discovering a cure to MS. MSYPN- our Young Professionals Network - wants you! For more information, please contact Mills at (303) 788-4030 ext. 111.

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Rocky Mountain Multiple Sclerosis Center 8845 Wagner St. | Westminster, CO 80031Administration 303-788-4030 | Fax 303-788-5418 | www.mscenter.org

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