| Eligibility |
Inclusion Criteria:
- Patients diagnosed with Parkinson's Disease as defined by the UK Parkinson's Disease
Society Brain Bank Criteria
- Be male or female between ages 30-85
- Be on at least two years of treatment of levodopa of at least 400 mg or 4mg/kg daily
- Have levodopa induced dyskinesia for at least 2 hours per day
- Have been on stable doses of all anti-Parkinson's medications for 30 days and be
willing to remain on the same doses throughout the course of the study
- The subject/caregiver must demonstrate ability to complete an accurate home diary
based on training and evaluation (visit 2)
- Female subjects not of childbearing potential
- infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or
tubal ligation), congenital anomaly such as Mullerian agenesis; or
- post-menopausal - defined as either
- A woman at least 40 years of age with an intact uterus, not on hormone
therapy, who has had at least 1 year of spontaneous amenorrhea with a
follicle-stimulating hormone level >40 mIU/mL
- A woman 55 or older not on hormone therapy, who has had at least 6 months of
spontaneous amenorrhea
- A woman at least 55 years of age with a diagnosis of menopause prior to
start of hormone replacement therapy.
- Male subjects, regardless of their fertility status, with nonpregnant women of
childbearing potential (WOCBP) partners must agree to either remain abstinent (if this
is their preferred and usual lifestyle) or use a highly effective (less than 1%
failure rate) method of contraception (such as combination oral contraceptives,
implanted contraceptives, or intrauterine devices) or effective method of
contraception (such as diaphragms with spermicide or cervical sponges) for the
duration of the study and until their plasma concentrations are below the level that
could result in a relevant potential exposure to a possible fetus, predicted to be 90
days following the last dose of study drug.
- Men and their partners may choose to use a double-barrier method of
contraception. (Barrier protection methods without concomitant use of a
spermicide are not an effective or acceptable method of contraception. Thus, each
barrier method must include use of a spermicide. It should be noted, however,
that the use of male and female condoms as a double barrier method is not
considered acceptable due to the high failure rate when these barriers' methods
are combined). Men with pregnant partners should use condoms during intercourse
for the duration of the study and until the end of estimated relevant potential
exposure in WOCBP (90 days).
- Men should refrain from sperm donation for the duration of the study and until
their plasma concentrations are below the level that could result in a relevant
potential exposure to a possible fetus, predicted to be 90 days following the
last dose of study drug.
Exclusion Criteria:
- Diagnosis of an atypical or secondary parkinsonian syndrome
- Lack of documented response to levodopa
- Prior exposure to ketamine within the last one year
- Significant history of premorbid psychiatric illness other than depression
- Currently taking psychotropic medications with significant dopamine receptor blocking
effects such as first-generation antipsychotic agents (clozapine, quetiapine,
pimavanserin are allowed as concomitant medications - see section 5.4)
- Have used antipsychotic medications, with the exception of clozapine, quetiapine,
pimavanserin in the 6 months prior to screening (Visit 1) and at any time during the
course of the study
- Cognitive impairment as demonstrated as a score of 20 or below on the Montreal
Cognitive Assessment (MoCA)
- Has a history of drug or alcohol dependence or abuse
- History of visual or auditory hallucinations (visual hallucinations will be acceptable
if scored 2 or less on UPDRS II)
- Serious or unstable medical condition that would increase risk in view of the
principal investigator.
- The subject is female, and is pregnant or lactating at the time of pregnancy or has
positive pregnancy test result at screening.
- Baseline BP >160/95 on average of three readings at the screening visit
- History of arrhythmia, unstable angina, or significant cardiac dysfunction
- Have significant central nervous system disease, other than PD, that may affect
cognition or the ability to complete the study, including but not limited to other
dementias (e.g., Alzheimer's disease [AD]).
- Have a history in the last 6 months of transient ischemic attacks or stroke.
- Have a history of intracerebral hemorrhage due to hypertension.
- Have a history of hypertensive encephalopathy.
- If the Investigator believes that the subject would not be a good fit for the study
for any reason.
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