Currently, there is no cure for Parkinson’s Disease, however, certain medications can help improve symtoms. A Phase 2 clinical trial is now aiming to explore the efficacy of ketamine as a treatment for symptoms caused by certain Parkinson’s medication.
More than ten million people across the globe are living with Parkinson’s Disease, a condition that affects the brain and is caused by a loss of nerve cells. Some treatments can help improve motor deficit symptoms, such as the medication levodopa and other dopamine agonists. These medications, which have been in use for nearly 50 years, restore the dopamine deficits in the brain caused by the lost nerve cells.
Years of using dopamine agonists, however, can cause dyskinesia in some patients, a condition characterised by involuntary muscle movements. The cause of this is currently not well understood.
One company, PharmaTher, is now aiming to find out if ketamine could be an effective treatment for levodopa-induced dyskinesia with a randomised, double-blind, active placebo-controlled Phase 2 “KET-LID” trial.
PharmaTher CEO, Fabio Chianelli, commented: “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.”
In 2016, the effectiveness of low-dose ketamine on levodopa-induced dyskinesia was highlighted in an analysis of Parkinson’s disease patients, who had received the drug for pain relief, when it was observed that the patients experienced an improvement in symptoms lasting several weeks beyond treatment.
The results were corroborated in a test of low-dose ketamine in a rodent levodopa-induced dyskinesia model, and has also been examined in a controlled study. A further study in 2020 provided pre-clinical evidence to support the repurposing of sub-anesthetic ketamine treatment for Parkinson’s patients with levodopa-induced dyskinesia.
An Investigational New Drug (IND) for the trial has been approved by the FDA, and, if the Phase 2 clinical study is positive, PharmaTher will request a meeting with the FDA to discuss moving to a Phase 3 clinical study in the first half of 2022.
