Anaphylaxis: An immediate and short-lived, usually severe reaction in which the body responds to what is perceived to be a foreign substance with exaggerated symptoms, such as extreme itching, swelling, and often life-threatening respiratory distress.
Axon: The long, thread-like part of a neuron, or nerve cell, along which nerve signals are conducted.
Black box warning: Black box warnings are designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug.
Central nervous system (CNS): Term used to describe the brain and spinal cord. The part of the body affected by MS.
Cerebrospinal fluid (CSF): A clear fluid that circulates in the space surrounding the brain and spinal cord.
Class I: “Class I” trials meet the highest standards of the American Academy of Neurology.
Cognitive difficulties: Term used to describe memory loss or difficulty concentrating or solving problems.
Double-blind: A strict way of conducting a clinical trial that helps to reduce the possibility of bias (unfair influence). In this type of trial, health care providers and participants are “blinded.” This means that neither knows what drug regimen the participant is taking.
Evoked potentials: A testing method that measures electrical activity in the CNS.
Inflammation: The body’s response to insult or injury resulting in increased blood flow with swelling, tenderness, redness, and/or heat.
Interferon: Protein made in the body that helps boost the body’s immune system and keeps a virus from multiplying. Synthetic forms of interferon are used in making interferon therapy.
Intramuscular (IM) injection: Injection with a longer needle that is given deep into the muscle tissue.
Lesion: Damaged area in the brain or spinal cord caused by demyelination (also called plaque or sclerosis).
Magnetic resonance imaging (MRI): A diagnostic procedure that produces images of different body parts and areas inside the body (can be used to detect plaques or scarring that might be caused by MS in the brain and spinal cord).
Malaise: A general feeling of bodily discomfort and being unwell.
MHC Class II modulator: A treatment for RRMS that is
presumed to change the way the immune system responds by working on inflammatory cells outside and inside the CNS.
Multicenter: A clinical trial that takes place at more than 1 medical center or clinic. The benefits of multicenter trials include a larger number of participants, different geographic locations, various ethnic groups, and the ability to compare results among different medical centers—all of which help remove bias from the study.
Multiple sclerosis: A disease that attacks the
CNS. With MS, the immune system creates swelling and causes damage to the nerve covering (called myelin) that protects the nerve fibers in the brain and spinal
cord. This damage prevents nerve cells from communicating properly to relay signals to and from other parts of the body.
Myelin: A soft, white coating that surrounds and protects nerve fibers in the CNS and the peripheral nervous system. Myelin also helps nerve fibers conduct electrical impulses.
Necrosis: Death or decay of tissue that results from loss of the blood supply and oxygen needed to keep tissue alive and healthy.
Neurodegeneration: Permanent damage or loss of nerve cells, which include neurons and axons.
Neurologist: Medical doctor (or physician) with specialized training in conditions that affect the nervous system; some have a specialized interest in MS, epilepsy, or Parkinson’s disease.
Neuron: The basic nerve cell of the nervous system. A neuron consists of a nucleus within a cell body and one or more extensions called dendrites and axons.
Neuropsychologist: A professional who does cognitive assessment and retraining of patients. Neuropsychologists specialize in brain-behavior relationships.
Neutralizing antibodies (NAbs): Proteins produced by the body that may block (“neutralize”) the effectiveness of a drug therapy.
Occupational therapist: A specialist in rehabilitating patients with cognitive problems. The occupational therapist focuses on restoring the patient’s ability to carry out daily tasks at home, at work, and in the community.
Oligoclonal bands: A series of distinct bands found in the immunoglobulin (a protein substance from
immune cells) of the cerebrospinal fluid (CSF). The bands may be present in other conditions, but are helpful in diagnosing MS if other MS symptoms are present.
Open-label study: A clinical study in which both the patients and doctors know what therapy the patient is taking.
Pivotal trial: A controlled trial to evaluate the safety and effectiveness of a drug in patients who have the disease or condition to be treated. These trials usually represent the most rigorous demonstration of the drug’s effectiveness and safety, and are the basis for filing with the Food and Drug Administration for approval to treat the disease.
Placebo: An inactive substance which helps to determine the effectiveness of a drug by giving researchers something to compare the active drug to.
Placebo-controlled: This study method compares people taking a drug with people taking placebo.
Plaque: Damaged area in the brain or spinal cord caused by demyelination (also called lesion or sclerosis).
Pregnancy category B: Safety category for pregnant women considering or taking medication. This category means that when the medication was administered to pregnant animals, there was no detectable harm to the fetus; these studies were not done in women. Because animal studies are not always predictive of human response, Pregnancy Category B medications should be used during pregnancy only if clearly needed.
Pregnancy category C: Safety category for pregnant women considering or taking medication. This category means that when the medication was administered to pregnant animals, there was some harm done to the fetus. Category C medication should be used only if clearly needed (that is, if you and your doctor determine that the benefits outweigh the risks).
Pregnancy category D: Safety category for pregnant women considering or taking medication. This category means that when the medication was administered to pregnant women there was evidence of risk to the fetus. Category D medication should be used only if clearly needed (that is, if the drug is needed in a life-threatening situation or safer drugs cannot be used or are not effective).
Primary endpoint: The main goal of a clinical trial.
Primary-progressive MS (also called PPMS): A less common form of MS than the relapsing-remitting form. PPMS makes up approximately 10% of all people with MS and is characterized by a slow but nearly continuous worsening of disease.
Progressive multifocal leukoencephalopathy (PML): A very rare and potentially fatal disease of the central nervous system (CNS).
Progressive-relapsing MS (also called PRMS): The rarest form of MS that affects approximately 5% of all diagnosed patients. People with PRMS may go through a steady worsening of their condition after being diagnosed. They may also experience clear, severe relapses with or without complete recovery.
Prospective study: This type of “forward-looking” study is designed with a specific goal (or endpoint) in mind.
Randomized: A randomized trial is a type of clinical trial where participants are randomly chosen to take either one drug regimen or another. This method reduces the bias that can negatively affect the validity of medical research.
Relapse: The worsening of MS symptoms or the appearance of new symptoms (also called attack, exacerbation, and flare-up).
Relapsing-remitting MS (also called RRMS): The most common form of MS; affects approximately 85% of people newly diagnosed. RRMS is characterized by relapses that are usually followed by partial or complete recovery.
Sclerosis: Hardening of tissue. In MS, sclerosis is the body’s replacement of lost myelin around the CNS nerve cells with scar tissue (also called lesion or plaque).
Secondary-progressive MS (also called SPMS): A stage of MS that may come after RRMS. People with SPMS may have occasional relapses, minor remissions, and plateaus. Late in the course of the disease, they may experience a progressive disability.
Spasticity: A state of increased muscle tone leading to muscle tightness, stiffness and spasms.
Speech/language pathologist: A specialist in rehabilitating patients who are having problems speaking and communicating.
Study duration: The agreed-upon length of time during which results are collected in a clinical study.
Subcutaneous injection: Injections with a shorter needle given into the fatty layer just under the skin.
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