This single-group, open-label trial (n=10) aims to assess the tolerability and efficacy of low-dose ketamine infusion in treating Levodopa-Induced Dyskinesia (LID) in patients with Parkinson’s Disease.
The University of Arizona is sponsoring this trial, led by Principal Investigator Scott J Sherman. The study aims to evaluate the effects of intermittent ketamine infusions on LID symptoms, including changes in patient diaries of dyskinesia and the Unified Dyskinesia Rating Scale (UDysRS) scores. Secondary objectives include observing ketamine’s impact on various Parkinson’s Disease symptoms, Levodopa side effects, chronic and acute pain, and quality of life.
The trial involves 10 volunteer subjects diagnosed with Parkinson’s Disease, aged between 30 and 85, who have been on stable levodopa treatment for at least two years, experiencing LID for a minimum of two hours per day. They must have stable doses of all anti-Parkinson’s medications and demonstrate the ability to complete accurate home diaries. Female subjects must not be of childbearing potential.
Exclusion criteria include atypical or secondary parkinsonian syndrome diagnosis, lack of response to levodopa, recent ketamine exposure, significant premorbid psychiatric illness, cognitive impairment, history of substance dependence or abuse, serious medical conditions, pregnancy or lactation, and certain cardiovascular conditions.
The study design involves intravenous ketamine infusions at varying rates over the course of the trial. Primary outcome measures include changes in UDysRS scores from baseline to week 2 and week 12. The trial began on July 28, 2019, with a planned completion date of August 25, 2023. Recruitment is currently closed.
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University of ArizonaDr Franscio Moreno at the University of Arizona has been exploring the potential of psychedelic's to treat OCD.