Phase I Open-label Study of Low-dose Ketamine Infusion Treatment in Levodopa-Induced Dyskinesia in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT06021756 |
Recruitment Status :
Active, not recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 27, 2023 | ||||||
First Posted Date ICMJE | September 1, 2023 | ||||||
Last Update Posted Date | September 1, 2023 | ||||||
Actual Study Start Date ICMJE | July 28, 2019 | ||||||
Actual Primary Completion Date | August 25, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in the Unified Dyskinesia Rating Scale (UDysRS) total score [ Time Frame: 2 and 12 weeks ] Change in the Unified Dyskinesia Rating Scale (UDysRS) total score from Baseline to Week 2 and 12
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase I Open-label Study of Low-dose Ketamine Infusion Treatment in Levodopa-Induced Dyskinesia in Parkinson's Disease | ||||||
Official Title ICMJE | 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 | ||||||
Brief 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. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
Other Name: Intervention: Ketamine i.v.
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Study Arms ICMJE | Experimental: 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.
Intervention: Drug: Intervention: Ketamine
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
9 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 25, 2023 | ||||||
Actual Primary Completion Date | August 25, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 85 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT06021756 | ||||||
Other Study ID Numbers ICMJE | 1903472458_ MOD00004091 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Scott Sherman, University of Arizona | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | University of Arizona | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Scott Richards | ||||||
Investigators ICMJE |
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PRS Account | University of Arizona | ||||||
Verification Date | August 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |