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Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson's Disease
Active not recruitingRegisteredCTG
A multi-centre, Phase II, randomized, double-blind, active placebo-controlled trial of sub‑anesthetic IV ketamine vs midazolam in patients with Parkinson's disease and levodopa‑induced dyskinesia (n=30).
Details
This prospective, double-blind, randomized, parallel two-arm trial compares low-dose intravenous ketamine infusions with an active placebo (midazolam) to evaluate effects on levodopa-induced dyskinesia in patients with Parkinson's disease.
Participants receive two scheduled infusion sessions (Day 1 and Day 5 ±2) with PK sampling around infusions; infusion rates for ketamine range 0.1–0.30 mg/kg/hr and for midazolam 0.009–0.027 mg/kg/hr to preserve blinding. Outcomes include change in dyskinesia severity and safety/tolerability measures.
Topics:Neurodegenerative Disorders
Registry
Registry linkNCT04912115