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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Vima Therapeutics • ClinicalTrials.gov ID: NCT07804615

Registry updated: 2026-09-11
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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?

Interventions

  • VIM0423 (Drug)
    VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
  • VIM0423 Placebo (Drug)
    Matching VIM0423 placebo product containing no active ingredient

Eligibility criteria

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.

Conditions

PARKINSON DISEASE (Disorder)

Locations

  • Vima Site #039 — Scottsdale, Arizona, United States
  • Vima Site #064 — Scottsdale, Arizona, United States
  • Vima Site #048 — Murrieta, California, United States
  • Vima Site #050 — Stamford, Connecticut, United States
  • Vima Site #065 — Altamonte Springs, Florida, United States
  • Vima Site #054 — Aventura, Florida, United States
  • Vima Site #008 — Miami, Florida, United States
  • Vima Site #046 — Naples, Florida, United States
  • Vima Site #053 — Palm Beach, Florida, United States
  • Vima Site #062 — Tampa, Florida, United States
  • Vima Site #047 — Atlanta, Georgia, United States
  • Vima Site #045 — Decatur, Georgia, United States
  • Vima Site #041 — Overland Park, Kansas, United States
  • Vima Site #043 — Baltimore, Maryland, United States
  • Vima Site #007 — Olney, Maryland, United States
  • Vima Site #002 — Farmington Hills, Michigan, United States
  • Vima Site #014 — Albuquerque, New Mexico, United States
  • Vima Site #055 — Amherst, New York, United States
  • Vima Site #024 — New York, New York, United States
  • Vima Site #052 — Patchogue, New York, United States
  • Vima Site #067 — Raleigh, North Carolina, United States
  • Vima Site #051 — Canton, Ohio, United States
  • Vima Site #016 — Memphis, Tennessee, United States
  • Vima Site #049 — Cypress, Texas, United States
  • Vima Site #063 — Dallas, Texas, United States
  • Vima Site #058 — Round Rock, Texas, United States
  • Vima Site #066 — Arlington, Virginia, United States
  • Vima Site #023 — Kirkland, Washington, United States
  • Vima Site #015 — Spokane, Washington, United States
  • Vima Site #060 — Toronto, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record