Division of GMP Publications
J


ohn Cuspilich
Send Comments to QA/RA Editor

Food and Drug Assistance - Resources for Industry and Consumers

 

 
 

Condition - Disease

Links & Resources

- Add an Forum -

Acne - see Skin Care

ADD and ADHD

AIDS/HIV

Allergies

Alzheimer's

Arthritis

Asthma

Autism

Back Pain

Birth Control

Cancer - Breast

Cancer - Prostate

Cholesterol

Common Cold  |  Flu

Crohn's & Colitis

Dental Health

Diabetes

Diet & Nutrition

Ear Disorders

Epilepsy

Erectile Dysfunction

Hair Loss

Headache | Migraine

Heartburn

Heart Attacks

Hepatitis

Hemorrhoids

Kidney

Lyme Disease

Men's Health

Multiple Sclerosis

Osteoporosis

Parkinson's

SARS

SIDS

Skin Care

Sleep Disorders

Smoking

Snoring

Stress | Depression

Stroke

Vitamins

Weight Control


 











 
Multiple Sclerosis (MS)

Clinical Trials  |  Add a link  |  Regulations  |  Discussion Board  |  Ask the Nurse | Last Update January 1st. 2009  |  About FDA.COM  | Media Kit

Also called: MS

Multiple sclerosis (MS) is a nervous system disease that affects your brain and spinal cord. It damages the myelin sheath, the material that surrounds and protects your nerve cells. This damage slows down or blocks messages between your brain and your body, leading to the symptoms of MS. They can include

  • Visual disturbances
  • Muscle weakness
  • Trouble with coordination and balance
  • Sensations such as numbness, prickling, or "pins and needles"
  • Thinking and memory problems

No one knows what causes MS. It may be an autoimmune disease, which happens when your body attacks itself. Multiple sclerosis affects woman more than men. It often begins between the ages of 20 and 40. Usually, the disease is mild, but some people lose the ability to write, speak or walk. There is no cure for MS, but medicines may slow it down and help control symptoms. Physical and occupational therapy may also help.

 

What is Multiple Sclerosis?

An unpredictable disease of the central nervous system, multiple sclerosis (MS) can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.  Many investigators believe MS to be an autoimmune disease -- one in which the body, through its immune system, launches a defensive attack against its own tissues. In the case of MS, it is the nerve-insulating myelin that comes under assault. Such assaults may be linked to an unknown environmental trigger, perhaps a virus.

Most people experience their first symptoms of MS between the ages of 20 and 40; the initial symptom of MS is often blurred or double vision, red-green color distortion, or even blindness in one eye.  Most MS patients experience muscle weakness in their extremities and difficulty with coordination and balance.  These symptoms may be severe enough to impair walking or even standing. In the worst cases, MS can produce partial or complete paralysis.  Most people with MS also exhibit paresthesias, transitory abnormal sensory feelings such as numbness, prickling, or "pins and needles" sensations.  Some may also experience pain.  Speech impediments, tremors, and dizziness are other frequent complaints. Occasionally, people with MS have hearing loss. Approximately half of all people with MS experience cognitive impairments such as difficulties with concentration, attention, memory, and poor judgment, but such symptoms are usually mild and are frequently overlooked.  Depression is another common feature of MS.

Is there any treatment?

There is as yet no cure for MS. Many patients do well with no therapy at all, especially since many medications have serious side effects and some carry significant risks.  However, three forms of beta interferon (Avonex, Betaseron, and Rebif) have now been approved by the Food and Drug Administration for treatment of relapsing-remitting MS. Beta interferon has been shown to reduce the number of exacerbations and may slow the progression of physical disability. When attacks do occur, they tend to be shorter and less severe.  The FDA also has approved a synthetic form of myelin basic protein, called copolymer I (Copaxone), for the treatment of relapsing-remitting MS. Copolymer I has few side effects, and studies indicate that the agent can reduce the relapse rate by almost one third. An immunosuppressant treatment, Novantrone (mitoxantrone), is approved by the FDA for the treatment of advanced or chronic MS.

One monoclonal antibody, natalizumab (Tysabri), was shown in clinical trials to significantly reduce the frequency of attacks in people with relapsing forms of MS and was approved for marketing by the U.S. Food and Drug Administration (FDA) in 2004.  However, in 2005 the drug’s manufacturer voluntarily suspended marketing of the drug after several reports of significant adverse events.  In 2006, the FDA again approved sale of the drug for MS but under strict treatment guidelines involving infusion centers where patients can be monitored by specially trained physicians.

 While steroids do not affect the course of MS over time, they can reduce the duration and severity of attacks in some patients.  Spasticity, which can occur either as a sustained stiffness caused by increased muscle tone or as spasms that come and go, is usually treated with muscle relaxants and tranquilizers such as baclofen, tizanidine, diazepam, clonazepam, and dantrolene. Physical therapy and exercise can help preserve remaining function, and patients may find that various aids -- such as foot braces, canes, and walkers -- can help them remain independent and mobile.  Avoiding excessive activity and avoiding heat are probably the most important measures patients can take to counter physiological fatigue.  If psychological symptoms of fatigue such as depression or apathy are evident, antidepressant medications may help.  Other drugs that may reduce fatigue in some, but not all, patients include amantadine (Symmetrel), pemoline (Cylert), and the still-experimental drug aminopyridine. Although improvement of optic symptoms usually occurs even without treatment, a short course of treatment with intravenous methylprednisolone (Solu-Medrol) followed by treatment with oral steroids is sometimes used.

What is the prognosis?

A physician may diagnose MS in some patients soon after the onset of the illness. In others, however, doctors may not be able to readily identify the cause of the symptoms, leading to years of uncertainty and multiple diagnoses punctuated by baffling symptoms that mysteriously wax and wane.  The vast majority of patients are mildly affected, but in the worst cases, MS can render a person unable to write, speak, or walk.  MS is a disease with a natural tendency to remit spontaneously, for which there is no universally effective treatment.

What research is being done?

The National Institute of Neurological Disorders and Stroke (NINDS) and other institutes of the National Institutes of Health (NIH) conduct research in laboratories at the NIH and also support additional research through grants to major medical institutions across the country.  Scientists continue their extensive efforts to create new and better therapies for MS.  One of the most promising MS research areas involves naturally occurring antiviral proteins known as interferons. Beta interferon has been shown to reduce the number of exacerbations and may slow the progression of physical disability. When attacks do occur, they tend to be shorter and less severe.  In addition, there are a number of treatments under investigation that may curtail attacks or improve function.  Over a dozen clinical trials testing potential therapies are underway, and additional new treatments are being devised and tested in animal models.

In 2001, the National Academies/Institute of Medicine, a Federal technical and scientific advisory agency, prepared a strategic review of MS research. To read or download the National Academies/Institute of Medicine report, go to: "Multiple Sclerosis: Current Status and Strategies for the Future."

NIH Patient Recruitment for Multiple Sclerosis Clinical Trials

Organizations

Multiple Sclerosis Association of America
706 Haddonfield Road
Cherry Hill, NJ   08002
webmaster@msaa.com
http://www.msassociation.org
Tel: 856-488-4500 800-532-7667
Fax: 856-661-9797

 
Multiple Sclerosis Foundation
6350 North Andrews Avenue
Ft. Lauderdale, FL   33309-2130
support@msfocus.org
http://www.msfocus.org
Tel: 954-776-6805 888-MSFOCUS (673-6287)
Fax: 954-351-0630

 
Accelerated Cure Project for Multiple Sclerosis
300 Fifth Avenue
Waltham, MA   02451
info-ninds08@acceleratedcure.com
http://www.acceleratedcure.org
Tel: 781-487-0008
Fax: 781-487-0009

 
National Multiple Sclerosis Society
733 Third Avenue
3rd Floor
New York, NY   10017-3288
nat@nmss.org
http://www.nationalmssociety.org
Tel: 212-986-3240 800-344-4867 (FIGHTMS)
Fax: 212-986-7981

 
American Autoimmune Related Diseases Association
22100 Gratiot Avenue
Eastpointe, MI   48201-2227
aarda@aarda.org
http://www.aarda.org
Tel: 586-776-3900 800-598-4668
Fax: 586-776-3903

 
National Rehabilitation Information Center (NARIC)
4200 Forbes Boulevard
Suite 202
Lanham, MD   20706-4829
naricinfo@heitechservices.com
http://www.naric.com
Tel: 301-459-5900/301-459-5984 (TTY) 800-346-2742
Fax: 301-562-2401

 
Clearinghouse on Disability Information
Special Education & Rehabilitative Services Communications & Customer Service Team
550 12th Street, SW, Rm. 5133
Washington, DC   20202-2550
http://www.ed.gov/about/
offices/list/osers
Tel: 202-245-7307 202-205-5637 (TTD)
Fax: 292024507636

 
National Ataxia Foundation (NAF)
2600 Fernbrook Lane North
Suite 119
Minneapolis, MN   55447-4752
naf@ataxia.org
http://www.ataxia.org
Tel: 763-553-0020
Fax: 763-553-0167

 
National Organization for Rare Disorders (NORD)
P.O. Box 1968
(55 Kenosia Avenue)
Danbury, CT   06813-1968
orphan@rarediseases.org
http://www.rarediseases.org
Tel: 203-744-0100 Voice Mail 800-999-NORD (6673)
Fax: 203-798-2291

 
Well Spouse Association
63 West Main Street
Suite H
Freehold, NJ   07728
info@wellspouse.org
http://www.wellspouse.org
Tel: 800-838-0879 732-577-8899
Fax: 732-577-8644

 
Paralyzed Veterans of America (PVA)
801 18th Street, NW
Washington, DC   20006-3517
info@pva.org
http://www.pva.org
Tel: 202-USA-1300 (872-1300) 800-424-8200
Fax: 202-785-4452

 
 
Related NINDS Publications and Information
 
Publicaciones en Español
 

Prepared by:
Office of Communications and Public Liaison
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Bethesda, MD 20892

NINDS health-related material is provided for information purposes only and does not necessarily represent endorsement by or an official position of the National Institute of Neurological Disorders and Stroke or any other Federal agency. Advice on the treatment or care of an individual patient should be obtained through consultation with a physician who has examined that patient or is familiar with that patient's medical history.

All NINDS-prepared information is in the public domain and may be freely copied. Credit to the NINDS or the NIH is appreciated.

Last updated December 01, 2008

 

 

Reference Links - Add a link

 

Clinical Trials - Add a clinical trial

 top
1 Not yet recruiting Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
Conditions: Relapsing-Remitting Multiple Sclerosis;   Secondary Progressive Multiple Sclerosis;   Progressive Relapsing Multiple Sclerosis
Intervention: Biological: Autologous mesenchymal stem cell transplantation
2 Recruiting Therapy Optimization in Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
Intervention: Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcu), and IFN-beta 1b
3 Recruiting Oral Cladribine in Early Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
Interventions: Drug: Oral cladribine;   Drug: Oral cladribine;   Drug: Placebo
4 Recruiting Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Interferon beta 1-a;   Drug: glatiramer acetate;   Other: placebo
5 Recruiting The Effects of TYSABRI Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention: Biological: TYSABRI (natalizumab)
6 Recruiting Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Biological: alemtuzumab;   Biological: interferon beta-1a (Rebif®)
7 Recruiting Assessment of Patients With Multiple Sclerosis (MS)
Conditions: Herpesviridae Infection;   HTLV-I Infection;   Multiple Sclerosis;   Tropical Spastic Paraparesis;   Vasculitis
Intervention:  
8 Recruiting Gene Expression Profiles in Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
Intervention: Procedure: Blood Draw
9 Recruiting Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Biological: alemtuzumab;   Biological: alemtuzumab;   Biological: interferon beta-1a (Rebif®)
10 Recruiting Brain Peripheral Benzodiazepine Receptors in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention:  
11 Recruiting Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
Condition: Multiple Sclerosis
Interventions: Drug: CDP323;   Drug: placebo;   Drug: CDP323
12 Not yet recruiting Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS
Condition: Multiple Sclerosis
Intervention: Dietary Supplement: Linoleic Acid/Oleic Acid
13 Recruiting Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Conditions: Relapsing Remitting Multiple Sclerosis;   Multiple Sclerosis, Chronic Progressive
Intervention: Drug: Ritalin
14 Recruiting Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Condition: Multiple Sclerosis
Interventions: Drug: Teriflunomide (HMR1726);   Drug: Placebo
15 Recruiting Phase II Cladribine Add-on to Inteferon-Beta (IFN-b) Therapy in MS Subjects With Active Disease
Condition: Multiple Sclerosis
Interventions: Drug: Cladribine;   Other: Placebo
16 Recruiting REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
Interventions: Drug: Rebif New Formulation (RNF);   Drug: Rebif New Formulation (RNF);   Drug: Placebo
17 Recruiting AT RISK FOR MS - Clinical Conversion of Female Monozygotic Twins Discordant for CIS/MS
Conditions: Multiple Sclerosis;   Clinically Isolated Syndrome
Intervention:  
18 Recruiting Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early MS Treatment With Betaseron
Conditions: Multiple Sclerosis;   Multiple Sclerosis, Relapsing-Remitting
Intervention:  
19 Recruiting fMRI Study of Treatment Recommendations Comparing Recently Diagnosed MS Patients to Controls
Condition: Relapsing-Remitting Multiple Sclerosis
Intervention: Drug: IFN-β-1a (Rebif®)
20 Recruiting Trial of Analgesia With Lidocaine or Extended-Release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Conditions: Neuropathic Pain;   Chronic Pain;   Multiple Sclerosis
Interventions: Drug: Lidocaine patch 5%;   Drug: Extended-release oxycodone;   Drug: Placebo extended-release oxycodone pills;   Drug: Placebo lidocaine patches

  Next (21-40)