Painkiller ketamine eases uncontrolled body movements in people with Parkinson’s disease, new research has revealed.
The Phase 2 trial evaluated how well a low dose of the drug that does not induce anaesthesia works to reduce levodopa-induced dyskinesia in 30 adults with the condition.
Patients treated with an intravenous ketamine infusion had a reduction in dyskinesia. The drug was well tolerated, with only mild to moderate side effects reported.
The company who sponsored the trial is now preparing to discuss plans for a Phase 3 clinical study with the FDA, where it plans to use its own ketamine candidate, Kerarx, over a longer period.
Fabio Chianelli, CEO of PharmaTher, said:
“We are very pleased with the results from this clinical study as it gives us further confidence that ketamine can safely and effectively reduce levodopa-induced dyskinesia in patients with Parkinson’s disease and it paves the way for a potential Phase 3 clinical study to support FDA approval via the 505(b)(2) regulatory pathway.”
Dyskinesia is a common side-effect of the prolonged use of Parkinson’s treatment, levodopa.
Previous studies have shown that most patients will develop dyskinesia after 10-12 year of taking the drug.
In the recent study, patients aged 30 to 85 were randomly assigned either a low dose of ketamine or the sedative midazolam for eight weeks.
The main aim of the study was to assess changes in the Unified Dyskinesia Rating Scale from the start to the end of the study.
Secondary aims included changes in the Unified Dyskinesia Rating Scale total objective, motor and dyskinesia scores and daily ‘off times’ after eight weeks of treatment.
Off times are periods where symptoms return even while medication is still being used.
“The results of this clinical study further support that ketamine is well-tolerated even in an older population of patients with advanced Parkinson’s disease,” said principal investigator, Scott Sherman, MD, PhD.
Sherman is an associate professor of neurology, directs the Movement Disorders Center at the University of Arizona College of Medicine, the Arizona Chapter of American Parkinson’s Disease Association, and the Parkinson’s Disease Program of the HealthSouth Rehabilitation Institute of Tucson.
Sherman added:
“This opens the door to a fast-track development of a novel non-surgical treatment for levodopa-induced dyskinesia that will fill a major gap in the existing therapeutic arsenal.”