Ketamine Advances as Treatment for Levodopa-induced Dyskinesia
The U.S. Food and Drug Administration (FDA) has approved PharmaTher‘s investigational new drug (IND) application for ketamine as a treatment for levodopa-induced dyskinesia in people with Parkinson’s disease.
The approval clears the way for PharmaTher to proceed with a Phase 2 clinical trial to study low-dose ketamine — an anesthetic available by prescription in the U.S. — in Parkinson’s disease.
“The FDA’s acceptance of our IND application for ketamine to treat Parkinson’s disease is a significant milestone for us,” Fabio Chianelli, CEO of PharmaTher, said in a press release.
“The IND paves the way for us to expeditiously evaluate ketamine and other psychedelics via the FDA regulatory pathway in various mental illness, neurological, and pain disorders,” he added.
The trial will be called “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.” t will evaluate the safety, efficacy, and pharmacokinetics — how a compound moves into, through, and out of the body — of ketamine in low doses for levodopa-induced dyskinesia.
Dyskinesia refers to uncontrolled, involuntary movements associated with the long-term use of levodopa. This standard Parkinson’s treatment raises dopamine levels in the brain, but is associated with dyskinesia in up to 80% of Parkinson’s patients after 10–12 years of use.
The company intends to recruit about 36 participants across eight study sites in the United States. Volunteers will be assigned randomly to receive either ketamine or midazolam, a sedative used for comparison as an active control.
The study’s primary goal is to assess changes in dyskinesia, as measured by the Unified Dyskinesia Rating Scale total score, from the study’s start (baseline) to week eight, approximately two months.
Secondary study goals include changes in total objective scores of the Unified Dyskinesia Rating Scale, total daily “off” times, and change in the Unified Parkinson Disease Rating Scale total and sum scores of motor and dyskinesia after eight weeks of treatment. “Off” times refer to periods of active Parkinson’s symptoms despite medication use. “Off” time frequency will be evaluated through 24-hour diaries maintained by study participants.
PharmaTher expects to begin enrolling patients in the third quarter of 2021, and to request a meeting with the FDA to discuss a Phase 3 study, should this first study prove successful.
“We are committed to building a rich product pipeline of novel uses, formulations and delivery methods of psychedelics,” Chianelli said, “and with our FDA IND in place, we now have the foundation in making PharmaTher a global leader in psychedelic-based therapeutics.”