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

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.

Trial Details

The primary objective is to determine the tolerability and efficacy of a low-dose ketamine infusion for the treatment of Levodopa-Induced dyskinesias (LID), both acutely and during post-infusion evaluation (week 2-6), as measured by a change in patient diaries of dyskinesia and the UDysRS. Secondary objectives include observing the effects of ketamine on various symptoms of Parkinson's disease and Levodopa side effects. This includes the duration of "off," "on without dyskinesia," and "troublesome dyskinesia" time during waking hours, effects on chronic and acute pain, quality of life, and other general PD symptoms as noted in the Unified Parkinson's Disease Rating Scale. There is no highly effective treatment for levodopa-induced dyskinesia. This research study will use intermittent infusions of ketamine, on 10 volunteer subjects, which could provide significant improvement in dyskinesia utilizing a novel mechanism of action compared to current treatment strategies. Positive results in this study could lead to new novel treatments for dyskinesia and further development for other PD symptoms such as depression and pain.

NCT Number NCT06021756

Data attribution

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