What is Multiple Sclerosis? Multiple Sclerosis (MS) is a chronic neurological disorder that affects the central nervous system, (CNS) comprised of the brain and spinal cord. In the CNS, nerve fibers or axons are surrounded by a layer of insulation called myelin. Myelin allows nerve signals to travel properly, In MS, the myelin is destroyed (demyelination) on the brain and spinal cord. The scarring, located at multiple sites in the CNS, disrupts transmission of messages that communicate a desired action from the brain, through the spinal cord, to various parts of the body. The inflammation produced by MS damages the axons themselves and can cause permanent loss of function. In the process, the cells that produce myelin can also be damaged. This limits the ability of the brain to repair damaged myelin. This is similar to a frayed electrical cord. The insulation assures that the electricity running along the wire reaches its destination without short-circuiting. In MS, the transmission along the nerve fibers “short-circuits,” becoming faulty or absent. This can cause problems with vision, coordination, sensation in the limbs, and other symptoms.   Buy Zithromax for treating bacterial infections, skin infections, sexually transmitted infectious diseases, urethritis. medicstar.com Buy Propecia Propecia is used to treat hair loss. Propecia is not addictive. www-medic.com Buy Brand Viagra Viagra is applied for the treatment of erectile dysfunction in men. Buy Viagra Super Force Buy Amoxicillin one of the best antibiotic. Amoxicillin used to treat infections caused by certain bacteria. medicstar.com The course of the disease varies greatly from person to person. It is impossible to predict the severity or progression in any given individual. To better develop appropriate management plans, MS is divided into four classifications: Relapsing-Remitting - clearly defined attacks lasting from days to weeks, with full recovery or with some remaining neurological symptoms and deficits upon recovery. Periods between relapses are stable and absent of disease progression. This is by far the most common form of the disease. Secondary-Progressive – begins initially with a relapsing-remitting course that becomes consistently progressive and includes occasional relapses and minor remission. Deficits are accumulated without recovery between attacks. Primary-Progressive – progression of level of disability from the onset without any distinct relapses of remissions. Temporary, minor improvements may be experienced. Progressive-Relapsing – clear progression in disability level from the onset, but also clear acute relapses that may or may not include memory. What Causes Multiple Sclerosis? Currently, the exact cause of MS remains unknown, but researchers believe that a combination of several factors may be involved. Studies are ongoing in the following areas: Immunologic Reaction MS is generally believed to be an autoimmune disease. This means that the immune system, which normally protects us from disease and infection, reacts against normally occurring antigens (proteins that stimulate an immune response) as if they were foreign. In other words, the body mistakenly attacks itself. While some component of myelin is believed to be the target of that attack, the exact antigen remains unknown. In recent years, researchers have identified the immune cells causing the attack and some of the factors that cause them to do so, as well as some of the sites (or receptors) on the attacking cells that appear to be drawn to the myelin to begin the destructive process. Viral or other Infectious Agents Some data suggest that a common virus or other infectious agent may play a role in the cause of MS. Whether it is a persistent viral infection or an immune reaction caused by a temporary viral infection in the CNS or elsewhere in the body is not yet known. Environmental studies suggest that some factor – probably infectious – must be encountered before the age of 15 in order for MS to develop later in life. Several viruses and bacteria, including Epstein-Barr, Chlamydia, pneumonia, measles, canine distemper, and human herpes virus-6 have been or are being studies to determine if they may trigger MS, but none have been definitively proven to do so as of yet. Environmental Factors Epidemiologists – scientists who study disease patterns – have learned that MS occurs more frequently in geographic locations that are farther from the equator. In an effort to understand the puzzling disease patterns found in MS, scientists continue to examine geographic, demographic, and genetic variables. For example, studies have shown that people born in a geographic location with a high incidence of MS, who move to a geographic location with a lower incidence of MS before the age of 15, will acquire the lesser risk associated with their new location. Such data suggest that exposure to some environmental factor or factors prior to puberty, such as diet, exposure to industrial toxins, or content in water or soil may predispose a person to develop MS later in life. Some researchers believe vitamin D, which the body produces naturally when the skin is exposed to sunlight, may be involved. People who live closer to the equator are continually exposed to greater amounts of sunlight. As a result, they tend to have higher levels of naturally – produced vitamin D, which is thought to have a beneficial impact on immune function and may help protect against autoimmune disease, like MS. Other scientists are studying MS clusters, or geographic areas in which there is a higher incidence of MS over a specific period of time. While it is hoped that such studies might offer insight into what triggers the disease, so far results have been inconclusive. Genetic Factors While MS is not believed to be a hereditary disease, having a family history of MS (particularly in a parent or a sibling) does not make a person more likely to develop it. In a family in which one parent has MS, the risk that their children will develop the condition is estimated to be between 2 and 5 percent. Studies have shown that there is a higher prevalence of certain genes in areas where MS seems to cluster, as well as in some families where there is more than one person with MS. It is speculated that MS develops because a person is born with a genetic tendency to react when exposed to some environmental agent that triggers an autoimmune response. New techniques are being used in an effort to identify the genes involved. Nevertheless, the genetic picture of MS remains largely unknown and is proving harder to understand than other autoimmune diseases. While some autoimmune diseases are causes by one or two malfunctioning genes, MS appears to involve defects in many genes, each with only a modest effect. Over the years, aspartame (an artificial sweetener), allergies, physical trauma, exposure to heavy metals, and environmental toxins have also been studied as potential causes of MS. Little or no evidence has been found to substantiate these claims. Who Gets Multiple Sclerosis? Statistics indicate that there are currently 350,000 to 500,000 people in the U.S. who have been diagnosed with MS. Two hundred people are diagnosed with MS every week and over 2.5 million people are living with the disease worldwide. However, because the Centers for Disease Control and Prevention does not require U.S. physicians to report new cases of MS and the symptoms of the disease can go unrecognized for some time, these numbers are only estimates. MS is more common in women, appears more frequently in Caucasians than in Hispanics or African Americans, and is relatively rare among Asians and certain other ethnic groups. MS is most commonly diagnosed in individuals between the ages of 20 and 50, although it can develop in young children and teens as well as older adults. Is Multiple Sclerosis Contagious or Fatal? MS is neither contagious nor fatal. People with MS have a life expectancy that is not really any different from the general population. The leading causes of death in the MS community are heart disease, cancer, and stroke. MS tends to affect quality of life, not quantity of life. There are unusual variants of MS than can be very aggressive and potentially shorten life, but these are not the norm. Symptoms of Multiple Sclerosis Common symptoms of MS include fatigue, weakness, spasticity, balance problems, bladder and bowel problems, numbness, vision loss, tremors and depression. Not all symptoms affect all MS patients. No two persons have the same complaints; no one develops all of the symptoms. Symptoms may be persistent or may cease from time to time. Most patients have episodic patterns of attacks and remissions throughout the disease course. Symptoms may remit completely, leaving no residual damage, or partially leaving degrees of permanent impairment. Because the symptoms that define the clinical picture of MS are the result of nerve lesions causing disturbances in electrical conduction in one or more areas of the CNS, the nature of the symptoms that occur is determined by the location of the lesion. For example: an optic nerve lesion may cause blurred vision; a brain stem lesion may cause dizziness or double vision; a spinal cord lesion may cause coordination/balance problems. Depending on the location of the lesion, the MS patient may experience the following signs & symptoms: LESION LOCATION: SIGNS/SYMPTOMS: Cerebrum & Cerebellum Balance problems, speech problems, coordination, tremors Motor nerve tracts Muscle weakness, spasticity paralysis, vision problems, bladder, bowel problems Sensory nerve tract Altered sensation, numbness, prickling, burning sensation The following list of symptoms followed by typical courses of treatment, are not the only symptoms to affect those with MS. These symptoms may be intermittent or persistent. Not all of these symptoms affect all patients. Fatigue: The most common complaint of MS patients is fatigue. Occurs in as many as 78% of patients, usually in the late afternoon and often subsides in the early evening. Modifying activities, occupational therapy, and medications. Numbness, Tingling, Burning Sensations: Sensory complaints occur in up to 55% of patients and are often the earliest symptoms of MS. Disturbances of feeling in the extremities or the trunk such as tingling, crawling sensations, feelings of swelling or numbness. Numbness also depends upon its cause. If severe neurological damage to the myelin sheath takes place, then numbness may remain. Medication, exercise, healthy diet, body cooling, acupuncture, or pointed pressure therapy. Tremors: Shaking or trembling of a limb or occasionally the head. Up to 50% report extremity ataxia (shaky movements or unsteady gait) or tremors. Tremors may come and go. This symptom of MS impairs mobility and often is associated with difficulty in balance and coordination. Exercises, physical therapy, occupational therapy, adaptive equipment, and medications. Balance/Coordination: Gait and balance disturbances are common with MS. Balance problems without vertigo may be more constant, causing the person to sway or stagger. Exercises, physical therapy, occupational therapy. Depression: As in most cases with the onset of an illness, depression is a frequent reaction. MS-related lethargy and fatigue may also be mistaken for depression or heighten its effects. Medications, counseling, and alternative treatment options. Spasticity: Occurs with the initial attack of MS in up to 41% of patients and is present in about 62% of patients with progressive disease. Occurs when opposing groups of muscles contract and relax at the same time. When spasticity is present, the increased stiffness in the muscles means that a great deal of energy is required to perform daily activities. Exercise, stretching, physical therapy, mechanical aids, and medications. Bladder: Increased frequency of urination, urgency, dribbling, hesitancy, and incontinence. Modifying activities, catheterization, and medications. Bowel: Constipation, diarrhea and incontinence. Dysfunction occurs in almost two thirds of patients during the disease course. Diet management, adequate fluid intake, and medications. Vision Loss: Rarely involves both eyes simultaneously, usually starts with blurred vision followed by vision loss from 20/20 to 20/30 to 20/40. Medications, eye patch. Cognitive and Emotional Dysfunction: Affects approximately 50% of MS patients. Involves memory, reasoning, verbal fluency and speed of information processing. Emotional changes include euphoria, depression. Memory problems are fairly common among people with MS. Memory and reasoning problems may affect between two thirds and three fourths of those diagnosed with MS to varying degrees. Consider other issues that may lead to memory problems such as depression, other illnesses, and normal absent-mindedness. If memory loss is a constant problem, there are certain "mnemonic" exercises that may help or, consult a physician. Some treatments may be available to enhance cognitive functioning. Sexual Difficulties: More than 90% of men and 70% of women with MS report some change in their sexual life after the onset of the disease. Some problems include decreased sexual drive, impaired sensation, diminished orgasmic response, and loss of sexual interest. Good communication between partners, counseling, medications. For further information on symptoms and symptom management, call our Program Services Department at 1-888-MSFOCUS(673-6287) or you can contact us by email: support@msfocus.org. How is Multiple Sclerosis Diagnosed? By themselves, there are no specific tests that can determine if a person has MS or is likely to have it in the future. Current diagnosis of definite MS involves both clinical (history and neurological exam) and paraclinical (MRI, Spinal Tap, Evoked potentials) evidence. The diagnosis evolves from a discussion between the patient and the physician. A careful medical history is taken; symptoms and signs are assessed. Other ailments are ruled out. The diagnosis is highly dependent on the accuracy of the patient’s medical history and the physician's skill in eliciting and evaluating this information. The diagnosis is sometimes obvious and sometimes very difficult. Even in the hands of experts, the diagnosis is correct only 90 - 95 percent of the time. The physician will ask about past surgeries, illnesses, allergies, any family neurological disorders including MS, geographic locations where you have lived, if adversely affected by heat, medications taken, history of substance abuse (alcohol, drugs, and tobacco). During the neurological examination the physician will check for exaggerated reflexes such as Babinski's reflex, an upward movement of the big toe when the sole of the foot is stimulated. For patients with balance and gait difficulties, an eye examination is done to determine optic nerve damage. The physician must be able to find neurological evidence of lesions or plaques in at least two distinct areas of the Central Nervous System white matter, evidence that the plaques have occurred at different points in time, and most importantly, that these plaques have no other reasonable explanation thus ruling out other illnesses that mimic MS. For some patients no tests beyond medical history and neurologic exam are necessary to diagnose. However, most physicians will not rely entirely on this type of evaluation and will do at least one other test to confirm the diagnosis. In this era, even a clear-cut diagnosis will usually be confirmed with an MRI of the brain, one of the major diagnostic tools currently used. For further information, call our Program Services Department at 1-888-MSFOCUS(673-6287) or you can contact us by email: support@msfocus.org. Why Do Doctors Feel That I Am Imagining My Symptoms? In the beginning phases of multiple sclerosis, diagnostic tests, such as MRI's, may be negative but the patient may experience subjective sensory symptoms. These symptoms can include numbness, tingling, or fatigue, and will not be seen on diagnostic tests. This leads doctors to believe there is no illness or that anxiety is present. You should also know that a clinical diagnosis of MS may take years. Often a physician observes a person over a period of time before reaching a diagnosis of MS. Neurologists are generally consulted and diagnostic tests such as MRI's, evoked response potential, and others may be used to help with a diagnosis. If you are not sure you have MS, don't be afraid to ask questions and to find out more about feelings and symptoms. Do not let symptoms continue without further investigation. Major Diagnostic tools MRI of the brain and spinal cord with contrast, FLAIR MRI (fluid-attenuated inversion recovery), evoked potentials, lumbar puncture (spinal tap) are the major diagnostic tools at this time. MRI is the most sensitive non-invasive method available to detect areas of demyelination, (damaged myelin surrounding the nerves). MRI is safe and accurate providing the clearest evidence of white matter lesions in the CNS, and is also used to monitor the disease. Flair MR with Echo-Planner technology significantly reduces the time necessary to complete the FLAIR sequence and the standard MRI, while giving a greater picture of lesions on the brain. Evoked Potential Tests include VEP, BAEP'S, and SSEP'S. A painless procedure where electrodes are placed on the head and body. Response is recorded to determine where delays in nerve transmission occur. VEP (visual evoked potentials) an electrical response to repeated visual stimuli to detect optic neuritis. BAEP (brain stem auditory evoked potentials) detect abnormalities in patients with demylenating lesions in the brainstem which cause delays in the transmission of sounds. SSEP (somatosensory evoked potentials) delivers brief electrical stimulus to the wrist or ankle. Permits detection of disruptions in the pathways from the arms and legs to the brain at very specific positions of the CNS. Spinal Fluid Analysis the brain, spinal cord are bathed in a fluid called cerebrospinal fluid (CSF). In some instances, the patient undergoes a lumbar puncture (spinal tap). This is done to make certain that some other disease is not masquerading as MS. The oligoclonal bands and the IgG index are abnormal in about 90% of MS patients. For further information, call our Program Services Department at 1-888-MSFOCUS(673-6287) or you can contact us by email: support@msfocus.org. Recommended Multiple Sclerosis Resources  29 Gifts: How a Month of Giving Can Change Your Life   The MS Recovery Diet   Real Living With Multiple Sclerosis Magazine Subscription   Cooking Well: Multiple Sclerosis: Over 75 Easy and Delicious Recipes for Nutritional Healing   Healing Multiple Sclerosis: Diet, Detox & Nutritional Makeover for Total Recovery   MS and Your Feelings: Handling the Ups and Downs of Multiple Sclerosis  Treatments for Multiple Sclerosis The necessity for early treatment in MS is becoming increasingly clear. The time has passed for the “wait and see how it goes” attitude before treatment is started. Studies indicate that early treatment delays disability, presumably by decreasing the injury to the nervous system caused by the disease. The treatment of MS generally falls into two categories: treatments that address symptom management, and treatments that change the course of the disease by modifying the number and severity of attacks and the progression of disability. There has been a significant progress in both types of treatments in the last decade. Six different products have been approved by the FDA as disease modifying treatments for MS since 1993. These included three interferon-beta products (Betaseron®, Avonex®, and Rebif®) and three unrelated products (Copaxone®, Tysabri®, Novantrone®). Interferon-Beta products Betaseron® (interferon beta-1b) was the first beta interferon to be approved and marketed in the USA. As with all beta-interferons, it shuts down the inflammation of MS lesions through various mechanisms including repairing the blood brain barrier and reducing the inflammatory process in the lesions. Betaseron decreases relapse rate, increases time between attacks, decreases the severity of attacks, while decreasing the amount of accumulated lesions seen on MRI. Betaseron is given every other day by means of subcutaneous injection (under the skin) providing the highest dose of interferon-beta available for treatment of MS. Betaseron is approved for relapsing-remitting MS, and a recent European study showed some efficacy in secondary progressive MS. Marketed by Berlex Laboratories, Inc. Avonex® (interferon beta-1a) has been shown to slow the rate of progression of disability in relapsing-remitting MS. It has been demonstrated to decrease the relapse rate and the amount of accumulated damage seen on MRI, but to a lesser extent than other available agents. Avonex is given as weekly intramuscular injection at a lower dose than Betaseron or Rebif. Avonex is indicated for the treatment of relapsing-remitting MS. Marketed by Biogen, Inc. Rebif® (interferon beta-1a) is identical in chemical structure to Avonex. However it is given in subcutaneous rather than intramuscular injections, and in higher and more frequent doses than Avonex. Rebif is effective in reducing the number and severity of relapses, delaying the progression of disability, and reducing the number of new and accumulated lesions seen on MRI. Rebif has been used in Europe and Canada for over five years but was only recently approved by the FDA for use in the US after a head-to-head comparison to Avonex (the EVIDENCE study) showed superiority of Rebif in all clinical and MRI outcome measures. It is approved for use in relapsing-remitting MS. Rebif is available in pre-filled syringes. Marketed by Serono, Inc. Glatiramer Acetate Copaxone® (glatiramer acetate) is different from beta interferon in chemical structure and mechanisms of action. It consists of a group of amino acids that looks something like myelin itself. It acts by suppressing the immune system's attack on myelin and possibly other mechanisms. It decreases the frequency and severity of attacks to the same extent as Betaseron and Rebif, but with slightly less effect on MRI lesions. Copaxone is administered daily by subcutaneous injection and is used for relapsing-remitting MS. A pre-filled syringe is available for ease of use. Marketed by Teva Neuroscience. A Monoclonal Antibody Tysabri (natalizumab) is the first humanized monoclonal antibody approved for the treatment of MS. Tysabri works by blocking the receptors on white blood cells that allow them to enter the brain and spinal cord. Keeping these cells out leads to a decrease in inflammation. Tysabri is administered by IV infusion once every four weeks. In 2004, one year’s data showed that Tysabri slows the progression of disability, has a positive effect on MRI, and those taking the drug could experience a two-thirds reduction in MS relapse rate, about double the benefits offered by other MS drugs. Tysabri can only be prescribed, distributed, and infused by prescribers, infusion centers, and pharmacies registered with the TOUCH Prescribing Program developed by Biogen Idec and Elan, manufacturers and distributors of the drug, in consultation with the FDA. The drug should be used as a montherapy in patients who have not responded adequately to or who cannot tolerate the other disease-modifying drugs. Mitoxantrone Novantrone® (mitoxantrone) is a reasonably nontoxic chemotherapy agent that slows disease progression in MS and lessens the number of relapses through its ability to suppress the activity of T cells and B cells. These white blood cells attack the myelin that protects nerve cells, and by doing so cause the scarring associated with MS. It is approved for worsening MS including secondary progressive and relapsing-remitting forms of the disease. It is usually used for a limited period of time and with a limited total number of doses. A cardiac evaluation should be done prior to starting this drug. Novantrone is typically administered intravenously once every three months for two years. Marketed by Immunex Corporation. Steroid Treatment For acute exacerbations, steroids have been reported to shorten the duration of acute attacks by lessening the swelling and inflammation in MS lesions. However they do not alter the frequency of exacerbations or the progression of the MS, and long term use should be avoided except in selected patients. Included are synthetic adrenal glutcocorticoids (corticosteroids) such as prednisone, prednisolone, methylprednisolone, betamethasone, and dexamethasone. Conclusion The treatment of MS has changed dramatically in the last decade. A more favorable outcome and better quality of life are definitely more attainable by people with MS through appropriate and aggressive management. Such management should consider all available options including: the medications mentioned above, symptomatic treatments, medical, rehabilitative and psychological approaches, alternative treatment options, and experimental treatments available through clinical trials in specialized MS centers. Your individual physician should be able to provide more detailed information and advise you regarding the suitability of these available options considering the current condition of your disease. Remember, EARLY TREATMENT MAKES A DIFFERENCE. For further information, call our Program Services Department at 1-888-MSFOCUS(673-6287) or you can contact us by email: support@msfocus.org. Alternative Treatment Options Many people with MS use complementary and alternative medicine (CAM), which refers to unconventional medical practices that are not part of mainstream medicine. The term complementary medicine refers to therapies that are used in addition to conventional medicine, while the term alternative medicine is used to describe treatment that is used instead of conventional medicine. Surveys have shown that approximately 90% of people who use CAM also use conventional medicine. Thus, a small fraction of people who use CAM do so in a truly alternative manner. One of the biggest testaments to the appeal of CAM is that approximately 85 million people have paid for it, out of their own pockets, to the tune of $10 billion a year. Studies reveal that at least one out of three people in the United States has tried CAM and a majority of physicians supports the use of one or more CAM therapies. Currently two-thirds of health maintenance organizations (HMO’s) offer some CAM to their members. The fact that over 125 medical schools, including Harvard, Albert Einstein College, Cornell, Duke University, Stanford University School of Medicine, now offer CAM to their patients, has eased the minds of many who once felt all doctors were highly opposed to alternative medicine. While methods of conventional medicine provide the greatest hope for understanding and curing MS, there are three areas of CAM that may be of interest to people with MS because conventional medicine does not, as of yet, have a cure: Health and Well Being – diet, exercise, herbs, vitamins, apitherapy, hyperbaric oxygen Stress - massage, reflexology, meditation, guided imagery, biofeedback, tai chi, yoga Symptom Management - acupuncture, ayurveda, homeopathy, chiropractic With a large number of people with MS pursuing CAM therapies, it is essential for people to be knowledgeable about the therapies they choose and for physicians, other healthcare providers, and CAM practitioners to be aware that multiple conventional and CAM therapies are in use and that interactions among them are possible. By focusing more attention on CAM, and increasing communication between patients and healthcare professionals, we may actually develop a new understanding of the disease process, perhaps even discovering new therapies Am I Going to End Up in a Wheelchair? The natural course of MS is highly variable, and it is impossible to predict the nature, severity or timing of progression in a given patient. Some people with MS will have a more progressive disease course than others. In some cases, the course of MS over the first five years may provide a clue to the progression of the disease over the next 10 years. Recent studies indicate that 90% of patients with minimal disability five years after onset were still ambulatory at 15 years. It is estimated that at 20 years after diagnosis, about 1/3 of people who receive no treatment may require a wheelchair or other assistive device. With the present immunomodulatory therapies, the goal is to slow the progression of disability. Some people with MS respond quite well and may have no progression over years. For others, the treatment may slow, but not stop the progression. It is important to be proactive and work with your healthcare provider in order to obtain the most appropriate treatment, thus obtaining the highest level of benefit. What Options Can Help Me? Early treatment makes a difference. The necessity for early treatment in MS is becoming increasingly clearer. The time has passed for the “let’s wait and see how it goes” attitude before treatment is begun. The message is that early treatment seems to delay disability presumably by decreasing the injury to the nervous system by the multiple sclerosis. The drugs used for treating MS are currently: Avonex, Betaseron, Copaxone, Tysabri or Novantrone. Another option is alternative healing modalities. Many people find a combination of the two choices can achieve the best results. Does diet affect multiple sclerosis? Although diet is not currently considered a causative factor in MS, anecdotal evidence abounds from individuals with MS who have experienced health benefits by changing their diet. Eating consistently well over a period of time may help reduce fatigue, improve bladder and bowel problems, increase energy, and prevent bone loss. It may also positively impact mental and emotional health, including memory and concentration. To learn more, request a copy of Nutrition & MS by calling 1-888-MSFOCUS (673-6287). Does Stress Affect Multiple Sclerosis? By understanding some of the psychological changes that accompany chronic disease, one may take an active role to achieve a more healthy mental state. Psychotherapy or counseling, and body cooling are ways one can relieve stress. Some prefer alternative treatment options, including relaxation techniques (exercise, yoga, massage therapy, meditation, biofeedback, and music) to learn ways to manage unavoidable stress. With MS, the stress that must be managed is the “distress” that may hamper our ability to cope with the events and people in our lives. Can I Get Pregnant Though I Have MS? For a woman with MS, the decision to have a baby can be more difficult. MS does not hinder a woman’s chance of becoming pregnant and carrying a child to full term. MS is only another factor in one’s decision to have a child, not the only one. Planning the pregnancy and getting all the information you need can make the decision process easier. Together with your partner, visit your neurologist and discuss current disease activity and possible progression. With a bit of flexibility and a creative, proactive approach on the part of both parents, solutions to various challenges presented by MS are attainable. Attend a local MS support group meeting and talk to others who are successfully parenting with MS. To learn more, request a copy of Pregnancy for Women with MS by calling 1-888-MSFOCUS (673-6287). More questions… The Multiple Sclerosis Foundation is pleased to answer any question you have about multiple sclerosis. If you have a question that was not addressed, please call our National Toll-free Helpline at 1-888-MSFOCUS (673-6287); or you can contact us by email: support@msfocus.org. Overview of Clinical Trials Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever. Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans. Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. Human Clinical Trial Phases Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing. Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies. Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug. Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study. Participating in a Clinical Trial For more detailed information and answers to frequently asked questions about participating in clinical trials, please visit Volunteering for a Clinical Trial. Funding Clinical Trials Funding for clinical research comes from the federal government such as the National Institutes of Health, the Department of Defense, the Department of Veteran's Affairs, and private industry such as pharmaceutical and biotech companies, medical institutions, and foundations. Listing of Multiple Sclerosis Trials This is a listing of U.S. and international clinical trials actively recruiting patients for multiple sclerosis. Use this listing to search for clinical trials by geographic region. Check back regularly, as this database is updated daily. Please note that the list includes only trials posted on www.CenterWatch.com and may not include all existing trials for MS. (Last reviewed 7/2009)