Trial now testing whether oral Parkinson’s med can stop tremor
Phase 2 study is recruiting at sites in US; initial results expected next year
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- A newly launched clinical trial is testing an oral medication that aims to stop tremor in adults with Parkinson’s disease.
- VIM0423 is designed for use by patients still experiencing the hallmark Parkinson's symptom while on other meds.
- The trial, called Vista PD trial, is now recruiting participants ages 18 to 65 at select U.S. study sites, with more slated to open.
A new clinical trial testing an oral drug for adults with Parkinson’s disease who continue to experience tremor despite being on standard therapies has launched in the U.S. — and is now recruiting in four states.
The Phase 2 trial, called Vista PD (NCT07804615), is assessing the safety and effectiveness of Vima Therapeutics‘ VIM0423, a potential once-daily treatment that aims to ease this hallmark symptom of Parkinson’s, which can still occur for some patients on medication. According to a company press release, the first participant has already been dosed, and initial data are expected in the second half of 2027.
The trial, which will test the drug’s effectiveness compared with a placebo, is now recruiting an estimated 80 people with Parkinson’s, ages 18 to 65, at selected clinical sites in the U.S. Additional study centers are expected to open across the country, along with one site in Canada.
Vima also announced that it’s advancing VIM0423 with support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF), which has granted funding through its Therapeutics Pipeline Program. That program aims to back promising therapies for Parkinson’s, and helps generate the evidence needed to move experimental treatments through later stages of clinical testing.
“The studies supported through this award will help generate clinical evidence on VIM0423, including its dosing and tolerability, and inform the next stages of development for its potential use in Parkinson’s,” said Catherine Kopil, PhD, the foundation’s senior vice president and head of clinical research, who noted that, among patients, “tremor is often reported as one of the most bothersome symptoms of Parkinson’s disease, particularly in the earlier stages of the disease.”
Parkinson’s is a progressive disease that gradually damages nerve cells, causing a range of symptoms. One of the most common is tremor, or involuntary shaking of the hands, arms, legs, or other parts of the body. It’s typically cited as one of the most troublesome Parkinson’s symptoms because it can interfere with everyday activities.
Developer award funding by The Michael J. Fox Foundation
Standard medications for Parkinson’s work by increasing dopamine, a neurotransmitter needed to help the body control voluntary movement that’s deficient in people with the disease. However, in about one-third of patients, these dopaminergic medications do not adequately control tremor.
“While there are many therapies approved for Parkinson’s disease, there are no approved therapies to specifically treat tremor,” said Bernard Ravina, MD, founder and CEO of Vima.
Kopil adds: “For many people [with Parkinson’s,] it remains difficult to adequately control [tremor] with existing therapies.”
Taken as a pill, VIM0423 targets muscarinic cholinergic receptors in the brain. These receptors regulate signals involved in controlling movement. Although targeting them is an established approach to treating motor symptoms, earlier therapies have often caused side effects. VIM0423 is designed to reduce these side effects while still controlling symptoms.
According to Ravina, “VIM0423 was developed to selectively target the muscarinic receptors involved in mediating this signaling, with improved efficacy and tolerability that has historically restricted this therapeutic approach.”
While there are many therapies approved for Parkinson’s disease, there are no approved therapies to specifically treat tremor.
The now-underway trial is enrolling individuals who have been diagnosed with idiopathic Parkinson’s, meaning their disease has no known cause. Participants will be randomly assigned to receive either the experimental therapy or the placebo, given daily for seven weeks.
Vista PD will involve two groups of patients: Those who continue to experience tremor despite being treated with levodopa or a dopamine agonist and those who have never used dopaminergic medications. Altogether, the clinical study will last up to 12 weeks, or about three months, and involve six in-person visits. Participants will wear a monitoring device and assess their tremor and its impact on everyday activities.
The main goal is to track changes in motor and nonmotor symptoms over six weeks using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale. Researchers will also track side effects and examine pharmacokinetics, or how VIM0423 moves into, through, and out of the body.
VIM0423 is also being tested in a separate Phase 2 clinical study (NCT07304089) for isolated dystonia, which causes involuntary muscle contractions that result in abnormal postures or repetitive movements. The U.S. Food and Drug Administration has granted VIM0423 fast-track designation to help accelerate its development and review for isolated dystonia.
Ravinia thanked the MJFF for its funding, saying: “We are grateful for the support of The Michael J. Fox Foundation as we advance our mission to help give people with movement disorders the freedom to move.”
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