NCT06021756

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

A Single-center Phase I Open-label Study of the Tolerability and Efficacy of Low-dose Ketamine Infusion for Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Levodopa-Induced Dyskinesia
• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Intervention: Ketamine	Ketamine will be administered as intravenous infusions with infusion rates ranging from 0.05 mg/kg/hr to 0.30 mg/kg/hr.

Timeline

• Start date: 2019-07-28
• Primary completion: 2022-08-25
• Completion: 2023-08-25
• First posted: 2023-09-01
• Last updated: 2023-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study