Phase I Open-label Study of Low-dose Ketamine... — Clinical Trial Details

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, congenital anomaly, or post-menopausal as defined in protocol)
Men with WOCBP partners must agree to effective contraception or abstinence and refrain from sperm donation for duration of study and 90 days after last dose.

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 (exceptions noted in protocol)
Use of antipsychotic medications (with specified exceptions) in the 6 months prior to screening or during study
Cognitive impairment (MoCA score ≤20)
History of drug or alcohol dependence or abuse
History of visual or auditory hallucinations (visual hallucinations acceptable if scored ≤2 on UPDRS II)
Serious or unstable medical condition increasing risk per investigator
Pregnancy or lactation or positive pregnancy test at screening
Baseline BP >160/95 (average of three readings at screening)
History of arrhythmia, unstable angina, or significant cardiac dysfunction
Significant CNS disease other than PD that may affect cognition or ability to complete study (e.g., other dementias such as Alzheimer's disease)
History in last 6 months of TIA or stroke
History of intracerebral hemorrhage due to hypertension or hypertensive encephalopathy
Any other reason investigator considers subject unsuitable for study.

Phase I Open-label Study of Low-dose Ketamine Infusion Treatment in Levodopa-Induced Dyskinesia in Parkinson’s Disease