Gilenya, an oral medication was approved by the US FDA to treat relapsing forms of MS
Gilenya is the first approved oral disease modifying treatment for MS. Combined data from a Phase II study and two Phase III trials showed that Gilenya reduces relapses, disability progression, MRI lesion activity, and brain atrophy progression (loss of brain tissue).
Read the full story on Gilenya for Multiple Sclerosis
What’s New in MS Research and Treatment
Dr. Fox was recently asked to talk about CCSVI and research into this topic on a National MS society webcast. Other MS researchers also comment on new directions in MS in this webcast. Dr. Fox's component is later in the program at 54 minutes.
Mellen Center receives large grant from the National MS society to perform a study of CCSVI in MS patients.
The Mellen Center Staff, under the direction of Dr. Robert J. Fox, our medical director, recently received an important grant from the National MS society to study ‘chronic cerebrospinal venous insufficiency’ (CCSVI), a new theory of what causes MS. The project will evaluate individuals with MS and compare their ultrasound and MR venography results with those of healthy controls and individuals with other neurological and autoimmune disorders. We are pleased to have this opportunity to scientifically and objectively evaluate this possible link between multiple sclerosis and the blood flow out of the brain and spinal cord.
The study at the Mellen Center will primarily involve patients already followed at the Mellen Center for the past 10 years in a long-term research study. We will therefore not be seeking additional MS patients for this initial study at this time. We are looking forward to completing this study as rapidly as is possible, and sharing these results with the MS society and our patients when we are able to.
Here are some links to the latest National MS Society announcement:
Researchers at the Cleveland Clinic led by Dr. Jeffrey Cohen have studied compound called fingolimod which could ultimately be used to treat multiple sclerosis patients
New hope for MS patients
Cleveland Clinic researcher discovers improved treatment.
By Carmen Angelo & Ken Robinson, Newsradio WTAM 1100
Thursday, January 21, 2010
Researchers at the Cleveland Clinic led by Dr. Jeffrey Cohen have studied compound called fingolimod which could ultimately be used to treat multiple sclerosis patients.
Fingolimod is an oral pill and turns out to be more effective than an improved injected medication. Dr. Cohen says they studied more than 1,200 patients who have relapsing-remitting multiple sclerosis.
The most common side effects of fingolimod have been head colds, headache, and fatigue. However there have also been a few cases of skin cancer.
The study's results: the compound was well tolerated by patients. MS is an auto immune disease in which the immune system mistakenly attacks normal tissues in the body.
In MS patients, the disease attacks the myelin in the central nervous system. In layman's terms, if you think of nerves as wires, myelin is the insulation of the nerves which protects the nerves.
Disease onset usually occurs in young adults, and it is more common in females. It has a prevalence that ranges between 2 and 150 per 100,000. MS was first described in 1868 by Jean-Martin Charcot.
Clevelandclinic.org/maps Launched to Help Patients and Visitors Find Their Way to Main Campus
A new Internet tool – clevelandclinic.org/maps – has been created to make it easier for patients and visitors to find their way to and around main campus.
The new site includes:
- Interactive 3-dimensional map of Cleveland Clinic’s main campus
- Virtual tours of key buildings on main campus
- Information about amenities and points of interest on campus and within the surrounding area (including dining, shops, lodging, places of worship and banks/ATMs)
- 2-dimensional maps of Cleveland Clinic facilities in northeast Ohio, and national and international locations
- Directory index of addresses, phone numbers and photographs of Cleveland Clinic facilities' (including community hospitals, family health centers, specialty centers)
- Driving directions to recommended parking garages, as well as walking directions from garages to any welcome desk or building
Once patients get here, the ask me site serves as an employee’s guide to the resources and information that patients need while they are visiting us.
Thanks to clevelandclinic.org/maps, patients will come to main campus better prepared to find their way around our buildings. Use the ask me site to answer questions, provide additional resources and make their stay as pleasant as possible. Walking directions, detailed maps and retail and dining locations, and more can be printed from the site.
Investigational Oral Compound to Treat MS Effective, According to Phase III Trial
Two oral medications (pills) to treat multiple sclerosis have received recent attention, fingolimod (also known as FTY720) and cladribine. These are not pill forms of medications already-approved for MS (Avonex, Betaseron, Copaxone, Extavia, Novantrone, Rebif, and Tysabri) but are new medications.
The results of the TRANSFORMS and FREEDOMS studies of fingolimod and the CLARITY study of cladribine were published in the New England Journal of Medicine on Wednesday January 20, 2010. Both medications were shown to reduce relapses (attacks), worsening of disability, and activity on MRI scans in patients with relapsing-remitting MS. Both medications were generally well-tolerated. There were a small number of serious infections and cancers, and further study is needed to determine whether they were related to the medications.
Overall, fingolimod and cladribine look promising. They have been submitted to the US Food and Drug Administration, but neither has been approved yet. We cannot prescribe either medication at this time. The potential cost and insurance coverage are unknown.
Chronic cerebrospinal venous insufficiency in relation to MS
Recent publications from a center in Italy have raised the idea that patients with MS may have an increased risk of narrowing of the veins draining the brain and spinal cord. They authors have suggested that such narrowing may cause MS and that opening the veins through various procedures may be beneficial. At the Mellen Center we are planning to investigate these concepts. We hope to investigate whether in our MS population similar vein narrowing can be seen, and if so, find the potential relationship with the course and type of MS. We are currently not seeking patients for this study.
Given the available preliminary data and potential risks of opening the veins, we do not feel it is appropriate to perform invasive procedures to open these veins as a treatment for MS. We are not offering such a treatment nor do we feel it would be safe to offer such a treatment until this issue has been studied in more detail. If we find that there is significant impairment in the veins of MS patients, we will then consider exploring treatment options.
Cleveland Clinic Receives $2.75 Million Grant To Study Stem Cell Treatment For MS
Jeffrey Cohen, MD, of Cleveland Clinic’s Mellen Center, will conduct a Phase I study to determine the feasibility and safety of using mesenchymal stem cells to treat MS
“Mesenchymal stem cells (MSCs) are primitive cells in the bone marrow that have a wide variety of effects that decrease the activity of specific types of immune cells which are over-active in MS,” Dr. Cohen said. “In addition, in numerous laboratory studies, MSCs were able to lessen nervous system damage by developing into cells resembling neurons and support cells and, probably more importantly, by creating a tissue network that reduces disease damage and encourages intrinsic repair mechanisms.”
Dr. Cohen’s study will involve 24 patients with relapsing MS who have moderate to severe disability, but who are still able to walk. Bone marrow will be removed from the participant’s hip, and MSCs will be grown in a laboratory. Then, the cells will be given back to the patients to see if they help improve their condition.
Multiple sclerosis (MS) is thought to be an autoimmune disease, in which the immune system mistakenly attacks normal tissues in the body. In MS, these attacks are aimed at the myelin in the central nervous system.
The central nervous system, which includes the brain and spinal cord, is made up of nerves that act as the body's messenger system. Each nerve is covered by a fatty substance called myelin, which insulates the nerves and helps in the transmission of nerve impulses, or messages between the brain and other parts of the body.
MS gets its name from the buildup of scar tissue (sclerosis) located in more than one area (multiple) of the brain and/or spinal cord.
Medications on the Move: Ampyra (dalfampridine, formerly fampridine-SR)
After years of research, Acorda Therapeutics, a biotechnology company, has received marketing approval from the FDA for Ampyra, an oral treatment to improve walking in patients with multiple sclerosis (MS). Dr. Francois Bethoux and other investigators at the Mellen Center have been involved in clinical trials of this new medication. Two large scale studies showed an approximately 25% improvement in the speed of walking, in 35% to 43% of patients with MS who received the medication. Ampyra demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). Ampyra is a symptomatic therapy, therefore it does not treat the underlying disease process. However, Ampyra can be used with all currently available disease-modifying therapies for MS.
Ampyra should not be taken by people who have a history of seizures, or who have impaired kidney function. There is a risk of seizures, which is low at the recommended dose. Other side effects reported in clinical trials included: back pain, fatigue, balance problems, falls, insomnia, urinary tract infections, dizziness, headache, nausea and throat pain, according to the FDA.
The medication is expected to be available in March 2010. The cost of the medication is not known, and insurance coverage will depend on individual plans. Please contact your neurologist or health care provider for further information on this medication.
Other symptomatic medications, rehabilitation, and certain devices, can also help improve walking performance in patients with MS. Our neurorehabilitation team is available to perform evaluations and discuss treatment options.
FIGHT MS... on a Bike
Support multiple sclerosis research by joining Team Mellen in riding in Bike MS: Pedal to the Point, Saturday and Sunday, Aug. 14 and 15. The ride (not a race) is a weekend bicycle-riding fundraiser for the National Multiple Sclerosis Society with 30-, 75- and 150-mile options through beautiful farm country with fully-outfitted rest stops.
This year's team, led by co-captains Dr Robert Fox and Physician Assistant Jen Hartman, has 68 riders and they've already raised $19,900, with a goal to raise $40,000. Over the past 7 years, almost $200,000 has been raised for MS patient care and research.
Why do they ride? Over the past four years, the NMSS has provided over $2.0 million in research funding, ranging from clinical and basic research projects to fellowships for clinicians and basic scientists. The NMSS also continues to provide a part-time social worker to the Mellen Center to help our MS patients access the social services that they need. Riding in the MS150 is a way for us to show our appreciation for this tremendous support. Many of our clinical and basic science projects are completely funded by the Society, and this support has helped to maintain the Mellen Center's reputation as a national leader in the field of multiple sclerosis care and research.
Team Mellen is open to all members of the Cleveland Clinic Foundation community – patients, employees, family, and friends.
If you want to get fit and join the fight against MS, then join Team Mellen! For further information contact team co-captains Jen Hartman, PA (firstname.lastname@example.org) or Robert Fox, MD.
An Aggressive Approach
By Georgiann Caruso as told to Cleveland Clinic Magazine
On Halloween weekend 2005, a stroll through a cornfield maze ended with a trip to the emergency room. I had trouble walking. Testing revealed I have multiple sclerosis, or MS, a disease of the central nervous system in which myelin, the insulation on nerve fibers, is lost. MS can be devastating. It was a shocker. I was only 28. I had been leading an active life, working hard for several years for CNN in Atlanta.
Copyright 1995-2007 The Cleveland Clinic Foundation. All rights reserved. Reproduction of this article is prohibited except with the prior written permission of Cleveland Clinic. This article is for educational purposes only and should not be relied upon as medical advice. It does not replace the independent judgment of a physician about the appropriateness or risks of a condition or procedure for a given patient.
MS services are now offered at Lakewood Hospital
For our patients’ convenience, patients with multiple sclerosis will have access to evaluations, follow-up care and treatment, close to home. Starting in January, Alex Rae-Grant, MD will be seeing patients at both Main Campus and Lakewood Hospital. Dr. Rae-Grant is board-certified in neurology and specializes in the care of patients with multiple sclerosis. He plays an active role at Cleveland Clinic Mellen Center overseeing education on multiple sclerosis in the northeastern Ohio region, assists with clinical trials, and is involved with resident and student education at the Clinic.
To schedule an appointment with Dr. Rae-Grant please call 216.529.7110 (Lakewood Hospital) or 216.445.2751 (Main Campus)
Reclaim Your Health!
It is time to turn your life around and join us for Lifestyle 180 (PDF), a six week wellness program. The focus of this program is to address lifestyle issues related to MS patients. The points of focus include: nutrition, exercise, stress management and disease specific therapy. After the completion of this program there will be five follow-up sessions over the next year. Please consider Lifestyle 180 for a lasting impact on your health and wellness. The cost of the program is $1,500. Lifestyle 180 program will be held at the Cleveland Clinic Lyndhurst campus.
For more information call 877.331.WELL (9353) or email Lifestyle180@ccf.org
The Mellen Center team (Jennifer Hartman PA-C, Robert Fox, MD, and Alex-Rae Grant, MD) was the recipient of the Outstanding Physician Assistant / Physician Team award for 2008