Please select the eligibility criteria that correspond to the clinical trial below.
Title: ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)
Brief Summary: This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.


Options:
A: Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.
* Clinically meaningful response to L-Dopa with well-defined early morning "OFF" episodes, as determined by the Investigator.
* Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit
* No planned medication change(s) or surgical intervention anticipated during the course of study.
* Patients must experience at least one well defined "OFF" episode per day with a total daily "OFF" time duration of ≥ 2 hours during the waking day, based on patient self-assessment.
* Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
* MMSE score \> 25.

Exclusion Criteria:

A patient will not be eligible for study entry if any of the following exclusion criteria are met:

* Atypical or secondary parkinsonism.
* Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; or Duodopa/Duopa.
* Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). Patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered.
* Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite); Tigan® (trimethobenzamide hydrochloride; patients from US sites only); or domperidone (patients from non-US sites only).
* Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
* Currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
* Drug or alcohol dependency in the past 12 months.
* History of malignant melanoma.
* Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
* Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
* History of clinically significant hallucinations during the past 6 months.
* History of clinically significant impulse control disorder(s).
* Dementia that precludes providing informed consent or would interfere with participation in the study.
B: Inclusion Criteria:

* Hoen and Yahr scale: 1-3 stage
* FAC ≤ 2
* Ranking scale score ≤ 3
* Stability of drug treatment for at least 1 month
* Geriatric Depression Scale 5-items: negative

Exclusion Criteria:

* Concomitant participation in other studies
* Lack of written informed consent
* Clinical dementia rating (CDR) score ≥ 3
* History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically
* Serious dysfunction of the autonomic system
* Severe behavioral syndromes not compensated by drugs
* Concurrent neurological diseases
* Severe systemic diseases with life expectancy \< 1 year
* Patients unable to follow up.
C: Inclusion Criteria:

* Signed a current IRB/REB/IEC-approved informed consent form;
* Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria;
* On a stable regimen of antiparkinson's medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation;
* Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (trained caregiver/study partner assistance allowed);
* Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis);

Exclusion Criteria:

* History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation);
* History of seizures within 2 years prior to screening;
* History of stroke or TIA within 2 years prior to screening;
* History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer, in situ cervical cancer, or other definitively treated cancer that is considered cured;
* Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening;
* If female, is pregnant or lactating;
* If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;
* Treatment with an investigational drug or device within 30 days prior to screening;
* Treatment with an investigational biologic within 6 months prior to screening;
* Current participation in another clinical trial;
D: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson disease
* Hoehn \& Yahr stages II-IV
* At least 1 year post-STN-DBS
* Able to provide informed consent

Exclusion Criteria:

* Diagnosis of atypical parkinsonism
* Hoehn \& Yahr stages I or V
* Evidence of dementia (MMSE \< 24/30)
* Inability to walk 10 meters with or without assistive device

Answer: C