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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

Vima Therapeutics · NCT07804615

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
80
US sites recruiting
1
Study start
September 2026
Record last updated
September 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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?

Being studied: VIM0423; VIM0423 Placebo

Conditions: PARKINSON DISEASE (Disorder)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Vima Site #002

    Farmington Hills, MI 48334

    Site contact: Study Director · 617-430-7027 · clinicaltrials@vimatx.com

Study contacts (from the official record)

  • Study Director · 617-430-7027 · Clinicaltrials@vimatx.com
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A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of… (NCT07804615) | Bored Studies