Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.


Options:
A: Inclusion Criteria:

* patients with mild to moderate idiopathic Parkinson's disease (PD) (Hoehn-Yahr stage between 1.5 and 3)

Exclusion Criteria:

* orthopaedic conditions restricting exercise, or deep brain stimulation surgery or evidence of dementia . Patients not able walk independently.
B: Inclusion criteria:

1. 18 years or over
2. Clinical diagnosis of Parkinson's disease
3. Clinical diagnosis of symptomatic neurogenic orthostatic hypotension

At their baseline visit (Visit 2), patients must demonstrate:

* a score of at least 3 or greater on the OHQ composite
* a score of at least 3 or greater on the clinician CGI-S
* a fall of at least 20 mmHg in their systolic blood pressure, or 10 mmHg in their diastolic blood pressure, within 3 minutes of standing 4. Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care

Exclusion Criteria:

1. Score of 23 or lower on the mini-mental state examination (MMSE)
2. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;

   - Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study
3. Concomitant use of anti-hypertensive medication for the treatment of essential hypertension
4. Have changed dose, frequency or type of prescribed medication, within two weeks of baseline visit (Visit 2) with the following exceptions:

   * Vasoconstricting agents such a ephedrine, dihydroergotamine, or midodrine
   * Short courses (less than 2 weeks) of medications or treatments that do not interfere with, or exacerbate the patient's condition under study (e.g. antibiotics)
5. Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse)
6. Women who are pregnant or breastfeeding
7. Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner
8. Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception
9. Untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the patient
10. Sustained severe hypertension (BP ≥ 180 mmHg systolic or ≥ 110 mmHg diastolic in the seated or supine position which is observed in 3 consecutive measurements over an hour)
11. Any significant uncontrolled cardiac arrhythmia
12. History of myocardial infarction, within the past 2 years
13. Current unstable angina
14. Congestive heart failure (NYHA Class 3 or 4)
15. Diabetic autonomic neuropathy
16. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ
17. Gastrointestinal condition, which in the Investigator's judgment, may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass)
18. Any major surgical procedure within 30 days of the baseline visit (Visit 2)
19. Previously treated with droxidopa
20. Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit (Visit 2)
21. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study. Additionally the Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.
C: Inclusion Criteria:

* Person is 18 to 80 years of age
* Person has been diagnosed with Parkinson's disease for at lease five (5) years
* Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours
* Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy
* Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment
* Person must be available for appropriate follow-up times for the length of the study

Exclusion Criteria:

* Person has any major illness or medical condition that would interfere with participation in the study
* Person currently suffers from untreated, major depression
* Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
* Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery
* Person has dementia
* Person has a history of seizures
D: Inclusion Criteria:

* clinical diagnosis of probable idiopathic Parkinson's disease
* in stable health
* male and female aged 30-83 yrs
* Hoehn and Yahr stage II through IV inclusive
* levodopa-induced dyskinesias present greater than 25% of waking day; rating equal or greater than 2 on item 32 of UPDRS
* dyskinesias moderately or severely disabling as determined by a rating of equal or greater than 2 on item 33 of UPDRS
* Mini-Mental state (MMSE) score of equal or greater than 26
* on a stable dose of levodopa for at least 30 days
* if subjects are taking dopamine antagonists, amantadine, MAO-B inhibitors (rasagiline only) or COMT inhibitors, doses must have been stable for at least 30 days

Exclusion Criteria:

* Secondary or non-idiopathic Parkinson's disease
* Subjects with parkinsonian symptoms who do not respond to levodopa therapy
* history of schizophrenia, or other DSM-IV TR axis 1 diagnosis sufficient to interfere with or affect study conduct or interpretation of results
* any history (past 5 years) of suicide or suicide attempt or thoughts or urges of suicide on direct questioning
* subjects who score 2 or higher on a single module of the Jay MIDI scale
* moderate or severe hallucinations, psychoses or delusions
* any medical condition or lab abnormality presenting an unwarranted risk in the opinion of the Investigator
* history of HIV positivity, AIDS, or active hepatitis determined by subject report
* female who is pregnant or breastfeeding
* female of childbearing potential not using double barrier method of birth control throughout the duration of the study
* receipt of a neurosurgical intervention (e.g. brain surgery)related to Parkinson's disease or any neurosurgical procedure sufficient to interfere with study conduct or interpretation of results
* must not have systolic blood pressure ≥150; diastolic ≥95.
* must not have ECG at screening judged clinically significantly abnormal by investigator
* must not have QTc \> 450 msec at ECG screen
* must not have current angina pectoris, history of ventricular arrhythmias, uncontrolled hyperthyroidism, known or suspected pheochromocytoma, symptomatic vasospastic disease, or active peptic ulcer
* must not have a history of stroke, transient ischemic attack (TIA) or myocardial infarction within the last 2 years
* must not have current drug or alcohol abuse within the last two years. Acceptable alcohol use is no more than 3 ounces of alcohol, 3 beers or 2 glasses of wine per day.
* must not be participating in another drug trial or have participated in another drug study in the last 30 days. Observational trials with no intervention are acceptable provided permission is obtained from the other study sponsor in writing.
* must not be unwilling or unable to swallow capsules
* must not have a positive urine test for cotinine at screening
* must not be a smoker, previous (less than 5 years since cessation) smoker or have regular exposure to second hand smoke
* must not be allergic to capsule excipients
* must not be allergic to ondansetron. If allergic, they may participate provided they understand there is no rescue medication for potential nausea or vomiting during the study
* must not have known sensitivity to nicotine or nicotine-containing products
* must not be taking any of the following medications or substances within a minimum of 30 days: nicotine, any form; CYP2A6 inducers or inhibitors during the course of the study or within 30 days of the planned initial dose (your investigator will have a full list of these drugs); Monoamine oxidase inhibitors (with the exception of rasagiline, which is allowed)(your investigator will have a full list of these drugs); apokyn (apomorphine), due to its contraindication with ondansetron); warfarin.

Answer: C