What this study is
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?
What's being tested
- VIM0423
Intervention · DRUG
VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
- VIM0423 Placebo
Intervention · DRUG
Matching VIM0423 placebo product containing no active ingredient
Study details
- 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
- Sponsor
- Vima Therapeutics
- Conditions
- PARKINSON DISEASE (Disorder)
- Enrolling
- 80 people
- Starts
- 2026-09
- Est. completion
- 2027-06
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (30)
30 openContact for every open site
- Study Director · Contact617-430-7027clinicaltrials@vimatx.com
Vima Site #039
Scottsdale, Arizona, United States
Not yet recruitingVima Site #064
Scottsdale, Arizona, United States
Not yet recruitingVima Site #048
Murrieta, California, United States
RecruitingVima Site #050
Stamford, Connecticut, United States
Not yet recruitingVima Site #065
Altamonte Springs, Florida, United States
Not yet recruitingVima Site #054
Aventura, Florida, United States
Not yet recruitingVima Site #008
Miami, Florida, United States
Not yet recruitingVima Site #046
Naples, Florida, United States
Not yet recruitingVima Site #053
Palm Beach, Florida, United States
Not yet recruitingVima Site #062
Tampa, Florida, United States
Not yet recruitingVima Site #047
Atlanta, Georgia, United States
Not yet recruitingVima Site #045
Decatur, Georgia, United States
RecruitingVima Site #041
Overland Park, Kansas, United States
Not yet recruitingVima Site #043
Baltimore, Maryland, United States
Not yet recruitingVima Site #007
Olney, Maryland, United States
Not yet recruitingVima Site #002
Farmington Hills, Michigan, United States
RecruitingVima Site #014
Albuquerque, New Mexico, United States
Not yet recruitingVima Site #055
Amherst, New York, United States
Not yet recruitingVima Site #024
New York, New York, United States
Not yet recruitingVima Site #052
Patchogue, New York, United States
Not yet recruitingVima Site #067
Raleigh, North Carolina, United States
Not yet recruitingVima Site #051
Canton, Ohio, United States
Not yet recruitingVima Site #016
Memphis, Tennessee, United States
RecruitingVima Site #049
Cypress, Texas, United States
Not yet recruitingVima Site #063
Dallas, Texas, United States
Not yet recruitingVima Site #058
Round Rock, Texas, United States
Not yet recruitingVima Site #066
Arlington, Virginia, United States
Not yet recruitingVima Site #023
Kirkland, Washington, United States
Not yet recruitingVima Site #015
Spokane, Washington, United States
Not yet recruiting
1 site outside the US
Vima Site #060
Toronto, Ontario, Canada
Not yet recruiting
Study team
Sponsor
Vima Therapeutics
Study ID VIM0423-251
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.