Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease
Brief Summary: This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug.

Symptoms of NOH may include any of the following:

* Dizziness, light-headedness, feeling faint or feeling like you may blackout
* Problems with vision (blurring, seeing spots, tunnel vision, etc.)
* Weakness
* Fatigue
* Trouble concentrating
* Head \& neck discomfort (the coat hanger syndrome)
* Difficulty standing for a short time or a long time
* Trouble walking for a short time or a long time

The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of idiopathic PD
* Able to provide informed consent
* Ability to ambulate ≥ 300ft with or without an assistive device
* Hoehn and Yahr stage 2-4

Exclusion Criteria:

* Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
* Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
* Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
* Inability to follow 2 step commands
* Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire
B: Inclusion Criteria:

* Parkinson's disease;
* ability to ambulate 50 feet;
* ability to cooperate with balance testing;
* vitamin D level less than 40ng/ml;
* balance problems;
* ability to walk 50 feet without the help of another person

Exclusion Criteria:

* MMSE \< 25;
* another neurological or orthopedic deficit that in the examiner's opinion would affect testing;
* history of renal stones or hypercalcemia;
* unwillingness to not be on other vitamin D supplementation during the study
C: Inclusion Criteria:

* Patients with idiopathic PD.
* Patients with motor fluctuations averaging at least 1 hour daily in the "OFF" state during the waking hours.
* Patients with a Modified Hoehn and Yahr stage ≤3 in the "ON" state.
* Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline.
* Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa.
* Patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to randomisation.

Exclusion Criteria:

* Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
* Patients with a clinically significant or unstable vascular disease.
* Patients who have undergone a neurosurgical intervention of PD.
* Patients with severe disabling dyskinesias.
* Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
* Patients with a Mini Mental State Examination (MMSE) score ≤24.
* Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.

Other inclusion and exclusion criteria may apply.
D: 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.

Answer: D