1. Activities of Daily Living (ADLs)

Routine activities of everyday life that people tend to do on a daily basis without needing assistance. There are six basic ADLs: eating, bathing, dressing, toileting, transferring (walking) and continence. An individual-s ability to perform ADLs is important for determining what type of long-term care (e.g. nursing home care or home care) and coverage the individual needs (i.e. government-funded health care or long-term care insurance).

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2. Adjunctive treatment

A drug added as a supplement to increase the efficacy/decrease side effects/change the pharmacokinetics (PK) of another already prescribed treatment, e.g. (i) improve efficacy of a first-line therapy, e.g. adding a dopamine agonist to patients on levodopa, (ii) improve the tolerability and safety of the first-line therapy, e.g. use of anticholinergics to patients on neuroleptics, and (iii)improve the PK/brain availability of the first-line therapy, e.g. COMT-inhibitors administered to patients on levodopa.

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3. Agonist

An endogeneous or exogeneous agent that mimics the action of hormones and/or neurotransmitters on their receptors to enhance the response. For example, dopamine agonists stimulate specific brain dopamine receptors to obtain motor response.

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4. Allodynia

Pain from mechanical or thermal stimuli which are not normally painful. Allodynia is not referred pain and can occur in other areas that are not stimulated.

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5. Alpha-aminoamide derivative

The chemical class to which both safinamide and ralfinamide belong. More specifically, it is an amide derivative of an alpha-amino acid.

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6. Alzheimer's disease

A progressive degenerative disease of the brain of unknown etiology, characterized by diffuse atrophy throughout the brain with characteristic pathological changes suggestive of degeneration, and/or necrosis. The disease is characterized by a progressive deterioration of memory, cognitive function and changes in personality. Death usually occurs within 7 to 10 years of the time of diagnosis in most patients.

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7. Benzodiazepines

A class of drugs with hypnotic, anxiolytic, anticonvulsant, amnestic and muscle-relaxant properties, which are used for short-term relief of severe, disabling anxiety, ­insomnia, and muscle relaxation for surgical procedures.

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8. Cannabinoid

A group of chemicals which activate the body-s cannabinoid receptors. Currently, there are three general types of cannabinoids: (i) herbal cannabinoids occur uniquely in the cannabis plant, (ii) endogenous cannabinoids are produced in the bodies of humans and other animals, and (iii) synthetic cannabinoids are similar compounds produced in a laboratory.

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9. Central Nervous System (CNS)

The nerves and cells of the brain and spinal cord.

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10. Chemical scaffold

Chemical structure subunit shared by the molecules of a given chemical class.

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11. Clinical Global Impression Scale

A scale which provides an overall assessment of the global severity of illness, and change in the clinical condition of the patients compared with pretreatment status.

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12. Daily motor fluctuations (the on/off effect)

An unpredictable succession of off  periods when ­patients experience full disability and on periods when the drug being administered is successfully alle­viating the patient-s symptoms.

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13. Dopamine

A neurotransmitter known to have multiple functions depending on where it acts. Dopamine-containing neurons in a specific area of the basal ganglia are destroyed in Parkinson-s disease victims.

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14. Dopamine reuptake

The active transport of dopamine from the synaptic cleft into the presynaptic neuron after it has performed its function of transmitting a neural impulse.

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15. Dopaminergic system

The system of nerve cells that uses dopamine as its neurotransmitter.

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16. Double-blind study

A clinical trial design in which neither the participating individuals (healthy volunteers or patients) nor the study staff know which participants are receiving the experimental drug and which are receiving placebo or another active treatment. Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome.

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17. Dyskinesias

Abnormal, involuntary body movements that can appear as jerking, fidgeting, twisting, and turning movements.

In the context of Parkinson-s disease, dyskinesias are often the result of chronic levodopa therapy. These motor fluctuations occur in more than half of PD patients with levodopa therapy. Dyskinesias most commonly occur at the time of peak levodopa plasma concentrations and are thus referred to as peak-dose dyskinesias. As patients advance, they may evidence diphasic dyskinesias, which occur when the drug concentration rises or falls.

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18. Endogenous

Produced or synthesized within the organism.

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19. EPO

European Patent Office.

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20. Executive function

Executive function is a collection of varying abilities that involve regulatory control over thought and behaviour in the service of goal-directed or intentional action, problem-solving, and flexible shifting of actions to meet task demands. Clinical data about executive function can be obtained by observing an individual-s ability to problem-solving in the natural environment and assessing how flexible a person is when faced with a changing routine. The major executive functions include response inhibition (which permits impulse control, resistance to ­distraction, and delay of gratification); non-verbal working memory (which permits the holding of events in the mind and allows self-awareness across time); verbal working memory (which comprises the internalization of speech and permits self-description, questioning and reading comprehension); and self-regulation of emotion and motivation (which permits motivation, ­persistence toward a goal, and emotional self-control).

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21. GABA

Gamma-Amino Butyric Acid, a neurotransmitter which acts at inhibitory synapses in the brain and spinal cord.

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22. Gastrointestinal

Relating to, or affecting both stomach and intestine or their functions.

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23. Glutamate

A salt or ester of levorotatory glutamic acid. Glutamic acid is an amino acid, one of the 20 building blocks of proteins. It is involved in ammonia metabolism and serves as an excitatory neurotransmitter.

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24. Half-life

The time required for half the amount of a drug introduced in an organism to be metabolized or excreted; most commonly refers to drug plasma levels.

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25. Inflammatory pain

Triggered by nerve endings that become irritated when surrounded by inflamed tissue.

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26. In vitro

A biological or chemical process occurring outside a living organism, i.e. conducted on cultured cells.

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27. In vivo

A biological or chemical process occuring inside a living organism.

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28. Ion channels

Pore-forming proteins that help to establish and control the voltage gradient that exists across the plasma membrane of all living cells by allowing the flow of ions down their electrochemical gradient. They are present in the membranes that surround all biological cells.

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29. Levodopa

A drug which is used to treat Parkinson-s disease which helps restore levels of dopamine, a chemical messenger in the brain responsible for smooth, coordinated movement and other motor and cognitive functions.

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30. Mania

Mania is a severe medical condition characterized by extremely elevated mood, energy, and unusual thought patterns.

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31. MAO-B (monoamine oxidase B)

An enzyme that is responsible for the metabolism of dopamine and phenylethylamine in the brain. Thus, inhibiting MAO-B is a therapeutic strategy for the treatment of PD.

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32. MAO-B inhibitor

A drug which inhibits the MAO-B enzyme activity.

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33. Mild Cognitive Impairment

Mild Cognitive Impairment is a general term most commonly used to describe a subtle but measurable memory disorder. According to this definition, a person with Mild Cognitive Impairment has memory problems greater than normally expected with aging, but does not show other symptoms of dementia, such as impaired judgment or reasoning.

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34. Mixed peripheral neuropathic pain

Peripheral neuropathic pain of different aetiologies.

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35. N-type calcium channels

A calcium channel subtype, belonging to the high-voltage-activated (HVA) calcium channels, that is particularly involved in the process of synaptic neurotransmitter release.

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36. Nerve Compression

Harmful pressure of a nerve especially in nerves that pass over rigid prominences, i.e. a rupture disc in the lower spine causing sciatica.

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37. Nerve Entrapment

When a nerve gets stuck to the soft tissue that surrounds it, i.e. muscles, fascia and ligaments.

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38. Neurodegenerative

Relating to or characterized by the degeneration of nervous tissue.

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39. Neuro-inflammation

Chronic sustained injury of the central nervous system, involving the response of microglial cells that contribute to further damage, worsening the disease progression.

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40. Neurons

Cells that constitute nervous tissue, that have the property of transmitting and receiving nervous impulses.

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41. Neuropathic Low Back Pain (NLBP)

Form of chronic pain initiated or caused by the presence of a primary lesion, damage or disruption to some components of sensory neurons involving the area from the lower rib cage to the gluteal folds, leading to aberrant transmission of pain signals.

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42. Neuropathic pain

The International Association for the Study of Pain (IASP) has defined neuropathic pain as pain initiated or caused by a primary lesion or dysfunction of the nervous system. These lesions may be in the peripheral or central nervous system, and frequently both systems are involved with chronic neuropathic pain states. Examples include phantom limb and spinal cord injury pain, painful diabetic neuropathy, post-herpetic neuralgia, sciatica, trigeminal neuralgia, and drug-induced (e.g., vinca alkaloids) neuropathy.

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43. Neurotransmitter

A chemical substance in the brain that either excites or inhibits neural function.

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44. New Chemical Entity (NCE)

A compound of a completely new chemical form, which has not been previously approved, and therefore can be patented.

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45. Nociceptors

Sensory receptors responsible for nociception, the perception of pain in response to potentially damaging stimulus.

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46. NSAIDs

Non-steroidal anti-inflammatory drugs.

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47. Off-label

The use of a drug for a medical condition other than for which it was officially approved and marketed.

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48. Onset of action

The length of time it takes for a medicine to start to work.

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49. On time

During on times, patients report they feel relatively fluid, clear, and in control of their movements. Often, symptoms of PD may be invisible to all but professionals.

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50. Open label

A study in which all parties (patient, physician and study coordinator) are informed of the drug and dose being administered.

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51. Opioids

A synthetic drug (such as methadone) possessing narcotic properties similar to opiates but not derived from opium.

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52. Parkinson-s disease (PD)

PD is a degenerative disorder of the central nervous system that affects the control of muscles, and so may affect movement, speech and posture. Parkinson-s disease belongs to a group of conditions called movement disorders. It is often characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia), and in extreme cases, a loss of physical movement (akinesia). The primary symptoms are the result of excessive muscle contraction, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high-level cognitive function and subtle language problems. PD is both chronic, meaning it persists over a long period of time, and progressive.

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53. Pivotal study

Usually a phase III study which presents the data that the governmental agencies responsible for approving the marketing of pharmaceutical products (e.g., the US FDA and EMEA) use to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.

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54. Placebo

An inactive substance designed to resemble the drug being tested. It is used as a control to rule out any psychological effects testing may present.

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55. Product Candidate (or clinical compound)

A molecule that is selected at the end of preclinical studies to be the subject of the clinical phase of development.

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56. Randomized/randomization

Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups should be comparable.

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57. Receptor

A protein complex within a cell or on the membrane surface characterized by selective binding of a specific substance and a specific physiologic effect that accompanies the binding.

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58. Restless Legs Syndrome (RLS)

RLS, a common, but often misdiagnosed or underdiagnosed, neurological sleep movement disorder which is characterised by a distressing urge to move the legs and sometimes also other body parts, usually accompanied by a marked sense of discomfort or pain in the leg or other afflicted body parts.  RLS is typically triggered by rest or inactivity and its symptoms are temporarily relieved or suppressed by movement.

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59. Reuptake

Reuptake is the process by which a neurotransmitter, after it has performed its function of transmitting a neural impulse, is transported back into the cell for reuse.

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60. Substance P

Substance P is a neuropeptide: a short-chain polypeptide that functions as a neurotransmitter and as a neuromodulator. It is a molecule that acts as a messenger for the sensation of pain.

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61. Substantia nigra

An area of the brain where there are cell bodies of dopaminergic neurons projecting to the striatum, a ­circuit involved in motor control. The death of dopaminergic neurons in the substantia nigra is one of the causes of PD.

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62. Titration-up

Administration of small incremental doses of a drug until a desired clinical effect is reached.

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63. Tricyclic

Molecular structures which contain three rings of atoms. The term tricyclic antidepressant is related to imipramine, desimipramine, amitriptyline, etc.

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64. Tetrodotoxin

A potent neurotoxin, extracted from puffer fish, that binds and blocks the great majority of sodium ion channels in cellular membranes.

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65. Tetrodotoxin-resistant

A sodium ion channel which is resistant to the blocking activity of TTX.

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66. Tetrodoxotin-sensitive

A sodium ion channel which is sensitive to the blocking activity of TTX.

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67. Tyramine

A monoamine compound derived from the amino acid tyrosine, a member of the phenethylamine family.

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68. UPDRS

The Unified Parkinson-s disease Rating Scale is the standard tool for tracking Parkinson-s disease progress and response to therapy, subdivided into three scales including cognitive and mood aspects (Part I), Activities of Daily Living (Part II) and motor aspects symptoms (Part III), as well as dyskinesia aspects (Part IV). A lower score indicates a better condition than a higher score.

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