Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
Brief Summary: This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.


Options:
A: 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
B: Inclusion Criteria:

* Patients with idiopathic PD, diagnosed according to the Brain Bank criteria of the UK Parkinson's Disease Society
* Living independently in the community
* Able to complete the trial questionnaires.

Exclusion Criteria:

* Atypical parkinsonian syndromes
* Hoehn \& Yahr stage 5
* Severe cognitive impairment
* Presence of major psychiatric disorders
* Severe co-morbidity (e.g. cancer) that interferes with daily functioning.
C: 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
D: Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
* Hoehn and Yahr Stage 1-3 in an "on" state;
* Require levodopa-containing medication regimen at least 3 times during the waking day;
* Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
* Are on stable PD medication regimen;
* Total daily LD dose \<1600 mg/day;
* Able to perform a spirometry maneuver in the ON and OFF states;
* Normal cognition confirmed by MMSE score ≥25

Exclusion Criteria:

* Pregnant or lactating females;
* Previous surgery for PD or plan to have stereotactic surgery during the study period;
* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
* Known contraindication to the use of levodopa;
* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
* Any contraindication to performing routine spirometry.

Answer: D