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RecruitingPhase 2

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 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits, 2 visits, 3 visits, 1 visit
  • Time periods mentioned: 7 weeks, 12 weeks, 4 weeks
  • Procedures mentioned: Pills, Heart tracing (ECG), Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants in Cohort 1 will be randomized (1:1) to receive either VIM0423 or matching placebo (up to 5 pills a day\[MO1.1\]\[TG1.2\]\[MO1.3\], taken once daily) for 7 weeks."
  • "Participants in Cohort 2 will be randomized (1:1) to receive either VIM0423 or matching placebo (up to 5 pills a day\[MO3.1\], taken once daily) for 7 weeks."
  • "The total time of participation in the trial is up to 12 weeks and requires 6 in person visits."
  • "The study schedule includes Screening and Baseline (up to 4 weeks, 2 visits), Treatment period (including taper, 7 weeks, 3 Visits), and Safety follow-up (1 week, 1 Visit)."
  • "Clinical labs, EKGs, and Adverse events will be monitored throughout the study."
  • "Participants will be asked to use a wearable device during the study and perform self-assessments of their Parkinson's tremor and its impact on their activities of daily living."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether VIM0423 can reduce shaking (tremor) in adults with Parkinson’s disease, compared with a placebo (a treatment with no active drug). It also checks safety, side effects, and effects on daily life. It includes people taking certain Parkinson’s medicines and people who have never taken them.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old at the screening visit. Women must not be pregnant.
  • Have a diagnosis of Parkinson’s disease with no known cause, with tremor as a main symptom, that meets the study’s rules.
  • Group 1: Take levodopa or a dopamine agonist by mouth. These medicines help with Parkinson’s symptoms. Your dose and schedule must be unchanged for at least 10 weeks before screening, with no changes planned during the study. Your total dose must equal at least 300 mg of levodopa per day.
  • Group 2: Have never taken levodopa or a dopamine agonist in any form, and have no plans to start them during the study.
  • Have tremor scores that meet the study’s rules.
  • Other study rules may apply.

Who can't join

  • Take any anticholinergic medicine within 7 days before screening. These medicines block a chemical messenger in the body.
  • Have had deep brain stimulation (implanted devices that send signals to the brain) or another invasive brain procedure, including focused ultrasound or radiation procedures that destroy targeted brain tissue.
  • Other study rules may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (29)

AZ

CA

CT

FL

GA

KS

MD

MI

NC

NM

NY

OH

TN

TX

VA

WA