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Testing VIM0423 for shaking not controlled by usual medicine

Researchers compare the study medicine VIM0423 with an inactive treatment, checking tremor, safety and how the body handles the medicine.

Testing a treatment or activity · Study reference: NCT07804615

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 18 years to 65 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria * Participant must be male or nonpregnant female between 18 and 65 years of age (inclusive) at Visit 1 (Screening). * Diagnosis of clinically probable or clinically established idiopathic Parkinson's disease (PD) at Visit 1 (Screening) established by the MDS 2015 criteria which must include tremor as one of the cardinal characteristics. * Cohort 1: Currently using levodopa (any oral form only) or oral dopamine agonist at a stable dose and regimen of at least 10 weeks prior to Visit 1 (Screening); with no anticipated changes to said therapies for the duration of the study; and on a minimum of 300 mg LEDD. Cohort 2: Individuals who are dopaminergic naïve, as defined by: no prior or ongoing usage of levodopa (in any form) or dopamine agonist (in any form), and no anticipated plans to initiate said therapies for the duration of the study. * The participants must meet protocol-specified requirements for baseline tremor scores. Exclusion Criteria * Currently (within 7 days of Screening) taking any anticholinergic medication. * Prior deep brain stimulation (DBS) or any other form of invasive neurosurgical intervention (including, but not limited to, magnetic resonance-guided focused ultrasound thalamotomy, ablative thalamotomy, gamma knife thalamotomy) Other protocol-specified inclusion and exclusion criteria may apply.
Full study name & original research details

Official study title

A Phase 2 Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy

Short title used by the registry

A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy

Original description

Vista PD is a randomized, placebo-controlled, multicenter study to evaluate the efficacy, PK, safety, and tolerability of VIM0423 in adults with Parkinson's disease tremor insufficiently responsive to dopaminergic therapy. The main objectives of this clinical trial are to determine the following: * Does VIM0423 therapy improve tremor symptoms in adults with Parkinson's disease? * Is VIM0423 well tolerated in individuals with Parkinsons's disease? and * Do the therapeutic effects of VIM0423 confer improvements on daily function and quality of life?

Further description from the registry

Parkinson's disease (PD) is the second most common neurodegenerative condition, with studies estimating US prevalence among individuals aged 45 years and older rising to approximately 1,238,000 by 2030. More than 75% of individuals with PD will experience resting tremor at some point during their disease course, and approximately 60% additionally suffer from a symptomatic tremor during action or movement, complicating functional tasks. The distress caused by PD tremor is profound, with individuals consistently identifying it as their "most bothersome" symptom in early disease, and more impactful than other motor and nonmotor symptoms. Despite the clear importance of this symptom to patient experience, significant unmet need in tremor management persists. Tremor-specific efficacy of dopaminergic therapy, the mainstay of early PD pharmacology, is often inconsistent or incomplete, giving rise to the clinical concept of "dopamine-responsive" versus "dopamine-refractory" tremor. Anti-tremor efficacy of anticholinergic agents has been recognized for decades; however, their clinical utility is limited by both central and peripheral adverse effects VIM0423 is being developed as an oral medication designed to improve the central and peripheral tolerability seen with other anticholinergic medications. Vista PD (Study VIM0423-251) is a Phase 2, multicenter study designed to assess the efficacy, PK, safety, and tolerability of VIM0423 in adults with Parkinson's disease tremor insufficiently responsive to dopaminergic therapy. Up to 80 individuals will be enrolled in the trial. Cohort 1 will be comprised of adults diagnosed with PD who are on stable and adequate dopaminergic therapy (oral levodopa or oral dopamine agonist only), with residual tremor. Participants in Cohort 1 will be randomized (1:1) to receive either VIM0423 or matching placebo (up to 5 pills a day\[MO1.1\]\[TG1.2\]\[MO1.3\], taken once daily) for 7 weeks. The Investigator and Participant will not know whether \[MO2.1\]patients are receiving VIM0423 or placebo, but that information will be available if needed. Cohort 2 will be comprised of adults diagnosed with PD who are dopaminergic naïve, as defined by: no prior or ongoing usage of levodopa (in any form) or dopamine agonist (in any form), and no anticipated plans to initiate said therapies for the duration of the study. Participants in Cohort 2 will be randomized (1:1) to receive either VIM0423 or matching placebo (up to 5 pills a day\[MO3.1\], taken once daily) for 7 weeks. The Investigator and Participant will not know whether patients are receiving VIM0423 or placebo, but that information will be available if needed. The total time of participation in the trial is up to 12 weeks and requires 6 in person visits. The study schedule includes Screening and Baseline (up to 4 weeks, 2 visits), Treatment period (including taper, 7 weeks, 3 Visits), and Safety follow-up (1 week, 1 Visit). Assessments of changes in Parkinson's disease will be made by study personnel. Clinical labs, EKGs, and Adverse events will be monitored throughout the study. Participants will be asked to use a wearable device during the study and perform self-assessments of their Parkinson's tremor and its impact on their activities of daily living.

Conditions reported: PARKINSON DISEASE (Disorder)

Study type
Interventional
Interventions
VIM0423; VIM0423 Placebo
Phases
PHASE2
Sponsor
Vima Therapeutics
Start date reported by registry
2026-09 (estimated)

Registry updated: 2026-09-11 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Study Director · 617-430-7027 · Clinicaltrials@vimatx.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Vima Site #039

Scottsdale, Arizona, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #064

Scottsdale, Arizona, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #048

Murrieta, California, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #050

Stamford, Connecticut, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #065

Altamonte Springs, Florida, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #054

Aventura, Florida, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #008

Miami, Florida, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #046

Naples, Florida, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #053

Palm Beach, Florida, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #062

Tampa, Florida, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #047

Atlanta, Georgia, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #045

Decatur, Georgia, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #041

Overland Park, Kansas, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #043

Baltimore, Maryland, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #007

Olney, Maryland, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #002

Farmington Hills, Michigan, United States

Recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #014

Albuquerque, New Mexico, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #055

Amherst, New York, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #024

New York, New York, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #052

Patchogue, New York, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #067

Raleigh, North Carolina, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #051

Canton, Ohio, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #016

Memphis, Tennessee, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #049

Cypress, Texas, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #063

Dallas, Texas, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #058

Round Rock, Texas, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #066

Arlington, Virginia, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #023

Kirkland, Washington, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #015

Spokane, Washington, United States

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Vima Site #060

Toronto, Ontario, Canada

Not yet recruiting

Study Director · 617-430-7027 · clinicaltrials@vimatx.com

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.