A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia

Conditions

• Dystonia

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

Stride Dystonia is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of VIM0423 in individuals with isolated dystonia. The main objectives of this clinical trial are to determine the following: * Does VIM0423 therapy improve dystonia symptoms compared to placebo? * Is VIM0423 well tolerated in individuals with isolated dystonia? and * Do the therapeutic effects of VIM0423 confer improvements on daily function and quality of life?

Key Dates

Start date

Feb 5, 2026

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Segmental/multifocal Active
  Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n\~40
• Placebo Comparator: Segmental/multifocal Placebo
  Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n\~40
• Active Comparator: Generalized Active
  Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n\~10
• Placebo Comparator: Generalized Placebo
  Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n\~10

Primary Outcome Measure

Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale [ Time Frame: From baseline to Week 14 ]

Central Contacts

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

Locations (37)

Find similar trials in Birmingham, AL

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