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

NCT06021756 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-09-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Scott Richards

    collaborator UNKNOWN

  • University of Arizona

    lead OTHER

Principal Investigators

  • Scott J Sherman · University of Arizona Health Sciences Center - Dep. of Neurology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-28
Primary Completion
2022-08-25
Completion
2023-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06021756 on ClinicalTrials.gov