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

NCT07804615 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VIM0423-251
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 30

Brief 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. 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?

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Parkinson Disease; Tremor; Movement Disorder

Outcome Measures

Primary Outcomes (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.

  From baseline to Week 6

Secondary Outcomes (5)

• Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician

  From baseline to Week 6

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

  From baseline to Week 6

• Clinical Global Impression of Change (CGI-C)

  From baseline to Week 6

• Patient Global Impression of Change (PGI-C)

  From baseline to Week 6

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

  From baseline to Week 6

Other Outcomes (1)

• Incidence and severity of treatment emergent adverse events (TEAEs)

  From baseline to Week 6

Study Arms (4)

Cohort 1

ACTIVE COMPARATOR

Participants receiving active (VIM0423) n\~25

Drug: VIM0423

Cohort 1 Placebo

PLACEBO COMPARATOR

Participants receiving placebo n\~25

Drug: VIM0423 Placebo

Cohort 2

ACTIVE COMPARATOR

Participants receiving active (VIM0423) n\~15

Drug: VIM0423

Cohort 2 Placebo

PLACEBO COMPARATOR

Participants receiving placebo n\~15

Drug: VIM0423 Placebo

Interventions

VIM0423 DRUG

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

Cohort 1; Cohort 2

VIM0423 Placebo DRUG

Matching VIM0423 placebo product containing no active ingredient

Cohort 1 Placebo; Cohort 2 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vima Therapeutics: lead

Study Sites (30)

Vima Site #039

Scottsdale, Arizona, 85251, United States

NOT YET RECRUITING

Vima Site #064

Scottsdale, Arizona, 85258, United States

NOT YET RECRUITING

Vima Site #048

Murrieta, California, 92562, United States

NOT YET RECRUITING

Vima Site #050

Stamford, Connecticut, 06905, United States

NOT YET RECRUITING

Vima Site #065

Altamonte Springs, Florida, 32714, United States

NOT YET RECRUITING

Vima Site #054

Aventura, Florida, 33180, United States

NOT YET RECRUITING

Vima Site #008

Miami, Florida, 33176, United States

NOT YET RECRUITING

Vima Site #046

Naples, Florida, 34105, United States

NOT YET RECRUITING

Vima Site #053

Palm Beach, Florida, 33407, United States

NOT YET RECRUITING

Vima Site #062

Tampa, Florida, 33602, United States

NOT YET RECRUITING

Vima Site #047

Atlanta, Georgia, 30328, United States

NOT YET RECRUITING

Vima Site #045

Decatur, Georgia, 30030, United States

NOT YET RECRUITING

Vima Site #041

Overland Park, Kansas, 66211, United States

NOT YET RECRUITING

Vima Site #043

Baltimore, Maryland, 21237, United States

NOT YET RECRUITING

Vima Site #007

Olney, Maryland, 20832, United States

NOT YET RECRUITING

Vima Site #002

Farmington Hills, Michigan, 48334, United States

RECRUITING

Vima Site #014

Albuquerque, New Mexico, 87106, United States

NOT YET RECRUITING

Vima Site #055

Amherst, New York, 14226, United States

NOT YET RECRUITING

Vima Site #024

New York, New York, 10019, United States

NOT YET RECRUITING

Vima Site #052

Patchogue, New York, 11772, United States

NOT YET RECRUITING

Vima Site #067

Raleigh, North Carolina, 27607, United States

NOT YET RECRUITING

Vima Site #051

Canton, Ohio, 44718, United States

NOT YET RECRUITING

Vima Site #016

Memphis, Tennessee, 38157, United States

NOT YET RECRUITING

Vima Site #049

Cypress, Texas, 77429, United States

NOT YET RECRUITING

Vima Site #063

Dallas, Texas, 75243, United States

NOT YET RECRUITING

Vima Site #058

Round Rock, Texas, 78681, United States

NOT YET RECRUITING

Vima Site #066

Arlington, Virginia, 22205, United States

NOT YET RECRUITING

Vima Site #023

Kirkland, Washington, 98034, United States

NOT YET RECRUITING

Vima Site #015

Spokane, Washington, 99202, United States

NOT YET RECRUITING

Vima Site #060

Toronto, Ontario, M5G 2C4, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Synucleinopathies; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Study Director

CONTACT

617-430-7027; Clinicaltrials@vimatx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study sponsor, participants, the CRO, Investigator, and all site personnel (except pharmacists and pharmacy staff) will be blinded to treatment assignments until the database has been locked and restricted from further edits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel cohorts of participants receiving active or placebo drug products

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (29)