Trial Testing Ketamine as Dyskinesia Treatment Soon Enrolling Patients
Launched by PharmaTher, the study will evaluate ketamine’s safety, efficacy, and pharmacokinetics — the medicine’s movement into, through, and out of the body — in treating dyskinesia, the uncontrolled, involuntary movements that affect many Parkinson’s patients following disease treatment.
“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinson’s disease patients,” Fabio Chianelli, the company’s CEO said in a press release.
A total of 30 patients with Parkinson’s, ages 30 to 85, are being recruited. More information is available here, although the study locations have not yet been listed. Potential participants should have been treated with levodopa therapy, at a daily dose of at least 400 mg, for the past three years.
According to PharmaTher, clinical trial start-up activities have been completed and “essential vendors” — including project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring — have been selected.
Dyskinesia is a common side effect of the prolonged use of levodopa, a Parkinson’s treatment that increases dopamine levels in the brain. Up to 80% of Parkinson’s patients taking levodopa will develop dyskinesia after 10–12 years of treatment, previous studies have shown.
Ketamine is approved by the FDA as an anesthetic and pain-relieving agent. Prior preclinical research suggests that low-dose ketamine can alleviate abnormal movements in a mouse model of levodopa-induced dyskinesia.
In this Phase 2 trial, participants will be randomly assigned to receive either low-dose ketamine or the sedative midazolam, delivered intravenously or into the vein, for eight weeks, or about two months.
The trial’s main (primary) goal is to assess changes in the Unified Dyskinesia Rating Scale total score from the study’s start (baseline) to week eight.
Additional (secondary) goals include a change in the Unified Dyskinesia Rating Scale total objective, motor, and dyskinesia scores, and total daily off times after eight weeks of treatment. Off times are periods when Parkinson’s symptoms return despite medication use.
If the outcomes of the Phase 2 trial are positive, PharmaTher will request a meeting with the U.S. Food and Drug Administration to obtain an agreement to advance to a planned Phase 3 clinical study. That trial is expected to start by June 2022.