Parkinson’s trial testing ketamine for dyskinesia is soon recruiting patients
A new phase 2 clinical trial will test the psychedelic pain reliever ketamine as a treatment for levodopa-induced dyskinesia in people with Parkinson’s disease.
The trial, called KET-LID (NCT04912115), is expected to start recruiting participants this month. The first results are expected by the end of the year.
Initiated by PharmaTher, the study will assess the safety, efficacy and pharmacokinetics of ketamine – the movement of the drug in, through and out of the body – in the treatment of dyskinesia, the uncontrolled involuntary movements that affect many Parkinson’s disease patients after treatment for the disease.
“The launch of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is an important milestone for PharmaTher and we are excited about the opportunity to advance a new therapeutic solution. potential for patients with Parkinson’s disease, ”Fabio Chianelli, said the CEO of the company in a press release.
A total of 30 Parkinson’s disease patients, aged 30 to 85, are being recruited. More information is available here, although study locations have not yet been listed. Prospective participants must have been treated with levodopa, at a daily dose of at least 400 mg, within the past three years.
According to PharmaTher, clinical trial start-up activities have been completed and “critical suppliers” – including project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, as well as management and monitoring of clinical sites – were selected.
Dyskinesia is a common side effect of prolonged use of levodopa, a treatment for Parkinson’s disease that increases dopamine levels in the brain. According to previous studies, up to 80% of Parkinson’s disease patients taking levodopa will develop dyskinesia after 10 to 12 years of treatment.
Ketamine is approved by the FDA as an anesthetic and pain reliever. Previous preclinical research suggests that low-dose ketamine may attenuate abnormal movements in a mouse model of levodopa-induced dyskinesia.
In this Phase 2 trial, participants will be randomized to receive either low-dose ketamine or sedative midazolam, given either intravenously or into a vein, for eight weeks, or about two months.
The primary (primary) objective of the trial is to assess changes in the Unified Dyskinesia Rating Scale total score from the start of the study (baseline) through week eight.
Additional (secondary) goals include a change in the Unified Dyskinesia Rating Scale total goal, motor and dyskinesia scores, and total daily downtime after eight weeks of treatment. Rest periods are times when symptoms of Parkinson’s disease return despite the use of medication.
If the results of the Phase 2 trial are positive, PharmaTher will request a meeting with the United States Food and Drug Administration to obtain agreement to move to a planned Phase 3 clinical study. This trial is expected to begin by June 2022.