A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia (Stride Dystonia)
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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?
Participation Requirements• Participant must be male or nonpregnant female between 18 and 65 years of age (inclusive) at Visit 1 (Screening).
• The participant has a clinical diagnosis of isolated dystonia for at least one year prior to Visit 1 (Screening); has two or more body regions affected by dystonia at Visit 1 (Screening); and has been confirmed by Investigator and Enrollment Authorization Committee.
• The participant may be untreated with BoNT; OR if the participant is being treated with BoNT as part of their standard of care for dystonia, they must meet protocol-specified criteria.
• The participants must meet protocol-specified requirements for baseline scores on the BFM and CGI-S.
Vima Site #033
NOT_YET_RECRUITING
Birmingham
Vima Site #004
RECRUITING
Scottsdale
Vima Site #039
NOT_YET_RECRUITING
Scottsdale
Vima Site #028
NOT_YET_RECRUITING
Sun City
Vima Site #042
NOT_YET_RECRUITING
Irvine
Vima Site #030
NOT_YET_RECRUITING
Los Angeles
Vima Site #019
RECRUITING
Denver
Vima Site #009
NOT_YET_RECRUITING
Gainesville
Vima Site #008
NOT_YET_RECRUITING
Miami
Vima Site #031
RECRUITING
Orlando
Vima Site #005
NOT_YET_RECRUITING
Atlanta
Vima Site #027
NOT_YET_RECRUITING
Chicago
Vima Site #041
NOT_YET_RECRUITING
Overland Park
Vima Site #032
NOT_YET_RECRUITING
Boston
Vima Site #043
NOT_YET_RECRUITING
Baltimore
Vima Site #007
RECRUITING
Olney
Vima Site #037
NOT_YET_RECRUITING
East Lansing
Vima Site #002
RECRUITING
Farmington Hills
Vima Site #038
NOT_YET_RECRUITING
St Louis
Vima Site #040
NOT_YET_RECRUITING
Fayetteville
Vima Site #014
RECRUITING
Albuquerque
Vima Site #024
RECRUITING
New York
Vima Site #024
NOT_YET_RECRUITING
New York
Vima Site #036
NOT_YET_RECRUITING
Rochester
Vima Site #035
NOT_YET_RECRUITING
Cincinnati
Vima Site #029
NOT_YET_RECRUITING
Portland
Vima Site #020
RECRUITING
Philadelphia
Vima Site #021
NOT_YET_RECRUITING
Charleston
Vima Site #016
RECRUITING
Memphis
Vima Site #006
NOT_YET_RECRUITING
Nashville
Vima Site #025
NOT_YET_RECRUITING
Dallas
Vima Site #026
RECRUITING
Georgetown
Vima Site #012
RECRUITING
Houston
Vima Site #013
NOT_YET_RECRUITING
Houston
Vima Site #011
RECRUITING
Richmond
Vima Site #023
RECRUITING
Kirkland
Vima Site #015
RECRUITING
Spokane
Primary
Study Director
Clinicaltrials@vimatx.com
617-430-7027
Start Date: 2026-02-05
Estimated Completion Date: 2027-05
Target number of participants: 100
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