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PARKINSON DISEASE (Disorder)Phase 2Vista PDNCT07804615

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

A Phase 2 study testing VIM0423 in people with PARKINSON DISEASE (Disorder), run by Vima Therapeutics at 30 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PARKINSON DISEASE (Disorder)
What is being tested?
VIM0423
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
30 sitesin 2 countries
Study dates
Sep 2026to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

30 sites in 2 countries

United States29 sites, 29 recruiting
  • Vima Site #014

    Albuquerque, New Mexico, 87106

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

    Not yet recruiting
  • Vima Site #065

    Altamonte Springs, Florida, 32714

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

    Not yet recruiting
  • Vima Site #055

    Amherst, New York, 14226

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

    Not yet recruiting
  • Vima Site #066

    Arlington, Virginia, 22205

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

    Not yet recruiting
  • Vima Site #047

    Atlanta, Georgia, 30328

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

    Not yet recruiting
  • Vima Site #054

    Aventura, Florida, 33180

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

    Not yet recruiting
  • Vima Site #043

    Baltimore, Maryland, 21237

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

    Not yet recruiting
  • Vima Site #051

    Canton, Ohio, 44718

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

    Not yet recruiting
  • Vima Site #049

    Cypress, Texas, 77429

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

    Not yet recruiting
  • Vima Site #063

    Dallas, Texas, 75243

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

    Not yet recruiting
  • Vima Site #045

    Decatur, Georgia, 30030

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

    Not yet recruiting
  • Vima Site #002

    Farmington Hills, Michigan, 48334

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

    Recruiting
  • Vima Site #023

    Kirkland, Washington, 98034

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

    Not yet recruiting
  • Vima Site #016

    Memphis, Tennessee, 38157

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

    Not yet recruiting
  • Vima Site #008

    Miami, Florida, 33176

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

    Not yet recruiting
  • Vima Site #048

    Murrieta, California, 92562

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

    Not yet recruiting
  • Vima Site #046

    Naples, Florida, 34105

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

    Not yet recruiting
  • Vima Site #024

    New York, New York, 10019

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

    Not yet recruiting
  • Vima Site #007

    Olney, Maryland, 20832

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

    Not yet recruiting
  • Vima Site #041

    Overland Park, Kansas, 66211

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

    Not yet recruiting
  • Vima Site #053

    Palm Beach, Florida, 33407

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

    Not yet recruiting
  • Vima Site #052

    Patchogue, New York, 11772

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

    Not yet recruiting
  • Vima Site #067

    Raleigh, North Carolina, 27607

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

    Not yet recruiting
  • Vima Site #058

    Round Rock, Texas, 78681

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

    Not yet recruiting
  • Vima Site #039

    Scottsdale, Arizona, 85251

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

    Not yet recruiting
  • Vima Site #064

    Scottsdale, Arizona, 85258

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

    Not yet recruiting
  • Vima Site #015

    Spokane, Washington, 99202

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

    Not yet recruiting
  • Vima Site #050

    Stamford, Connecticut, 06905

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

    Not yet recruiting
  • Vima Site #062

    Tampa, Florida, 33602

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

    Not yet recruiting

Other trials in United States

Canada1 site, 1 recruiting
  • Vima Site #060

    Toronto, Ontario, M5G 2C4

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

    Not yet recruiting

Other trials in Canada

About this study

Official 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

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?
Read the detailed description

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.

Being tested
VIM0423, VIM0423 Placebo
Keywords
Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Parkinson Disease, Tremor, Movement Disorder
Medical subject headings
Parkinson Disease, Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Tremor, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIM0423Drug

    VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)

  • VIM0423 PlaceboDrug

    Matching VIM0423 placebo product containing no active ingredient

Study groups in NCT07804615
Study groupRoleWhat they receive
Cohort 1Active comparatorParticipants receiving active (VIM0423) n~25
Receives: Drug: VIM0423
Cohort 1 PlaceboPlacebo comparatorParticipants receiving placebo n~25
Receives: Drug: VIM0423 Placebo
Cohort 2Active comparatorParticipants receiving active (VIM0423) n~15
Receives: Drug: VIM0423
Cohort 2 PlaceboPlacebo comparatorParticipants receiving placebo n~15
Receives: Drug: VIM0423 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The MDS-UPDRS is a multi-part assessment designed to evaluate various aspects of PD and its impact on the individual, including motor and non-motor symptoms. There are four parts, all of which will be completed in this study: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part has varying maximum scores. In all cases, a higher score represents a more severe status.

    Measured: From baseline to Week 6

Secondary outcomes (5)
  1. Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician

    The CGI-S assesses the clinician's impression of the participant's current illness state. The clinician should use his/her total clinical experience with this population and rate the current severity of the participant's PD on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill).

    Measured: From baseline to Week 6

  2. Change from baseline in Tremor Research Group Essential Tremor Rating Scale - Activities of Daily Living (TETRAS-ADL)

    The TETRAS-ADL is a standardized assessment of the impact of tremor on activities of daily living in individuals with essential tremor. There are 12 items: speaking; feeding with a spoon; drinking from a glass; hygiene; dressing; pouring; carrying food on trays, plates or similar items; using keys; writing; working; overall disability; social impact. Each item is scored 0 (normal) to 4 (severe/severely abnormal), for a total possible score of 48, with a higher score indicated a worse impact of tremor.

    Measured: From baseline to Week 6

  3. Clinical Global Impression of Change (CGI-C)

    The CGI-C assesses the clinician's impression of how the participant's current illness has changed relative to baseline/pre-study. The clinician should use his/her total clinical experience with the individual participant and rate the participant's change in signs and reported symptoms using the scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), or 7 (very much worse).

    Measured: From baseline to Week 6

  4. Patient Global Impression of Change (PGI-C)

    The PGI-C is a written scale which will be used to solicit the participant's self-report of overall difference in PD related symptoms compared to his/her pre-study baseline. The score for each timepoint will be: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), or 7 (very much worse).

    Measured: From baseline to Week 6

  5. Change from baseline in Scales for Outcomes in Parkinson's Disease (SCOPA) - Sleep

    The SCOPA-Sleep is a validated patient-completed scale for assessing various components of sleep in individuals with PD: use of medication for sleep (2 items), nighttime sleep (5 items), global evaluation of sleep (1 item), and daytime sleepiness (6 items). A higher score represents a worse outcome.

    Measured: From baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel cohorts of participants receiving active or placebo drug products
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07804615
Sponsor's protocol ID
VIM0423-251
Acronym
Vista PD
Status last verified
Aug 2026
First submitted
31 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIM0423 in people with PARKINSON DISEASE (Disorder), run by Vima Therapeutics at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (617-430-7027, Clinicaltrials@vimatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: From baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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