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

Conditions

• PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• VIM0423 — DRUG
  VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
• VIM0423 Placebo — DRUG
  Matching VIM0423 placebo product containing no active ingredient

Study Details

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?

Key Dates

First listed

Sep 4, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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

• Study Director
  617-430-7027
  [email protected]

Locations (29)

Find similar trials in Scottsdale, AZ

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