Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia
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|ClinicalTrials.gov Identifier: NCT04912115|
Recruitment Status : Suspended (Seeking Pivotal study initiation)
First Posted : June 3, 2021
Last Update Posted : September 29, 2022
|Condition or disease||Intervention/treatment||Phase|
|Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations||Drug: Ketamine Drug: Midazolam||Phase 2|
This Phase II trial is a prospective, double-blind, randomized, parallel trial-design with two arms. Subjects will be randomized to treatment with the investigational product (ketamine) or an active control (midazolam). The active control causes mild sedation and is employed to minimize unmasking of the test article.
The study is an out-patient study. However, infusion days and days involving prolonged assessments are expected to require the subject to be onsite. Subjects will return to the site for safety and efficacy evaluations. On Day 1, PK samples will be collected near the end of Infusion 1 and post-infusion to evaluate near-steady-state blood levels in all subjects. Intensive PK sampling will be conducted in all subjects prior to, during, and a few hours after Infusion 2 (Day 5 ± 2).
The primary objective of the study is to evaluate the effects of low-dose intravenous infusion of ketamine on levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. All patients included in the study should meet the inclusion criteria. Half of the participants will receive ketamine, while the other half will receive active placebo (Midazolam). All participants will be assigned to either the active group or the control group randomly. During the clinical trial, both investigators and patients are double-blind except serious adverse events occurred.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo- Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa- Induced Dyskinesia in Subjects With Parkinson's Disease|
|Actual Study Start Date :||October 5, 2021|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||March 30, 2023|
Ketamine will be administered as intravenous infusions with infusion rates ranging from 0.1 mg/kg/hr to 0.30 mg/kg/hr. To maintain blinding, both active and placebo will be infused at similar infusion rates (mL/hr).
Ketamine is an FDA-approved N-methyl-D-aspartate (NMDA) receptor-modulating drug pharmacologically classified as an NMDA receptor antagonist (also noted to be a weak opioid receptor agonist).
Active Comparator: Midazolam
Midazolam will be administered as intravenous infusions with infusion rates ranging from 0.009 mg/kg/hr to 0.027 mg/kg/hr. To maintain blinding, both active and placebo will be infused at similar infusion rates (mL/hr).
Midazolam is a benzodiazepine used for anesthesia, procedural sedation, trouble sleeping, and severe agitation.
- Change in the Unified Dyskinesia Rating Scale (UDysRS) total score from Baseline to Week 8. [ Time Frame: 8 weeks ]The change from baseline to week 8 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The Unified Dyskinesia Rating Scale (UDysRS) is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
- Change in total daily OFF times as assessed by subject completed 24-hour diaries, from Baseline to Week 8. [ Time Frame: 8 weeks ]Change in daily "OFF"-time as assessed with patient diaries from run-in to week 8. This is a self administered diary where patients assess their motor state every half hour during 24 hours.
- Change in the UPDRS total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV from Baseline to Week 8. [ Time Frame: 8 weeks ]Change in MDS-UPDRS sum score of part III (Motor Examination) from baseline to week 8. Minimum value is 0 and maximum value is 124. Higher score mean a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04912115
|United States, Arizona|
|Investigative Site #7|
|Tucson, Arizona, United States, 85719|
|United States, California|
|Investigative Site #2|
|Chula Vista, California, United States, 91910|
|Investigative Site #1|
|Fountain Valley, California, United States, 92708|
|United States, Florida|
|Investigative Site #3|
|Miami, Florida, United States, 33032|
|Investigative Site #6|
|Miami, Florida, United States, 33175|
|United States, Illinois|
|Investigative Site #5|
|Rolling Meadows, Illinois, United States, 60008|
|United States, Michigan|
|Investigative Site #4|
|Plymouth, Michigan, United States, 48170|
|Study Director:||Study Director||PharmaTher Inc.|