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

NCT07804615

Not Yet RecruitingPhase 2

Sponsor: Vima Therapeutics

Conditions: PARKINSON DISEASE (Disorder)

Interventions: VIM0423, VIM0423 Placebo

Countries: United States, Canada

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?

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (30)
  • Scottsdale, Arizona, United States
  • Scottsdale, Arizona, United States
  • Murrieta, California, United States
  • Stamford, Connecticut, United States
  • Altamonte Springs, Florida, United States
  • Aventura, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Palm Beach, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Overland Park, Kansas, United States
  • Baltimore, Maryland, United States
  • Olney, Maryland, United States
  • Farmington Hills, Michigan, United States
  • Albuquerque, New Mexico, United States
  • Amherst, New York, United States
  • New York, New York, United States
  • Patchogue, New York, United States
  • Raleigh, North Carolina, United States
  • Canton, Ohio, United States
  • Memphis, Tennessee, United States
  • Cypress, Texas, United States
  • Dallas, Texas, United States
  • Round Rock, Texas, United States
  • Arlington, Virginia, United States
  • Kirkland, Washington, United States
  • Spokane, Washington, United States
  • Toronto, Ontario, Canada