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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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).
Midazolam is a benzodiazepine used for anesthesia, procedural sedation, trouble sleeping, and severe agitation.
Investigative Site #7
Tucson, Arizona, United States
Investigative Site #2
Chula Vista, California, United States
Investigative Site #1
Fountain Valley, California, United States
Investigative Site #3
Miami, Florida, United States
Change in the Unified Dyskinesia Rating Scale (UDysRS) total score from Baseline to Week 8.
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.
Time frame: 8 weeks
Change in total daily OFF times as assessed by subject completed 24-hour diaries, from Baseline to Week 8.
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.
Time frame: 8 weeks
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.
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.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigative Site #6
Miami, Florida, United States
Investigative Site #5
Rolling Meadows, Illinois, United States
Investigative Site #4
Plymouth, Michigan, United States