Updated: Apr 4, 2022
A Canadian biotech company recently announced the results of their Phase 2 study that explored the viability of using ketamine as a treatment for Levodopa-Induced Dyskinesia (“LID”) in patients with Parkinson’s Disease.
Parkinson's disease characterized by uncontrollable shaking and difficulty in motor coordination, balance, and walking is a debilitating brain disorder with no known cures and very few treatment options to reduce the symptoms. The most common treatment option for Parkinson's is a drug called Levodopa. While this drug on the short term is helpful in controlling the symptoms, over time, its side effects mimic Parkinson's disease itself.
The prognosis is grim: within 5 years, about 50% of the patients taking Levodopa will experience a resurgence of involuntary and uncontrollable physical movements, and in 10 years, nearly every patient will be experiencing these symptoms. This condition is Levodopa-Induced Dyskinesia or LID for which there are currently no known treatments.
In the study conducted by PharmaTher, researchers aimed to assess “the safety, tolerability and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s Disease.” The company reported favorable results across the dimensions of efficacy, safety, and tolerability.
According to the company's press release, “100% of patients treated with ketamine demonstrated a reduction in dyskinesias (LID) compared to pre-treatment baseline”. While the clinical data has not yet been published and we are unable to assess the severity of cases and reduction percentages, this report seems promising nevertheless.
The company also reported that their safety data suggested that the treatment was well-tolerated without serious adverse effects. The reported adverse responses were in line with expectations for side-effects of ketamine administration. These findings further supported the Phase 1 study results that found positive impact of ketamine in reducing LID.
Dr. Scott Sherman, MD, PhD, Principal Investigator of the Study, commented: “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. This opens the door to a fast-track development of a novel non-surgical treatment for levodopa-indued dyskinesia, that will fill a major gap in the existing therapeutic arsenal.”
Dr. Scott Sherman is the Associate Professor of Neurology and Director of the Movement Disorders Center at the University of Arizona College of Medicine, Medical Director of the Arizona Chapter of American Parkinson’s Disease Association, and Director of the Parkinson’s Disease Program of the HealthSouth Rehabilitation Institute of Tucson.
The company has announced plans to approach the FDA to prepare for the Phase 3 clinical study that will allow for ketamine’s approval as a treatment for Parkinson’s disease. If approved, for the nearly 1 million Americans that live with the disease and the estimated 60,000 that are diagnose annually, this treatment can improve both the quality and extension of life.