Recruiting
Phase 2

VIM0423

Sponsor:

Vima Therapeutics

Code:

NCT07804615

Conditions

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

VIM0423

VIM0423 Placebo

Study Details

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)

Study ID

NCT07804615

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cohort 1

Participants receiving active (VIM0423) n\~25

placebo comparator: Cohort 1 Placebo

Participants receiving placebo n\~25

active comparator: Cohort 2

Participants receiving active (VIM0423) n\~15

placebo comparator: Cohort 2 Placebo

Participants receiving placebo n\~15

Interventions

VIM0423

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

VIM0423 Placebo

Matching VIM0423 placebo product containing no active ingredient

Primary outcome measure

  • Change from baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: From baseline to Week 6 ]

Central Contacts and Locations

Central contacts

Study Director

617-430-7027Clinicaltrials@vimatx.com

Locations

Vima Site #002

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

More Information

Sponsor

Vima Therapeutics

Last update posted

Sep 11, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Vima Therapeutics on 2026-09-11.