A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
ConditionDystonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVima Therapeutics
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be male or nonpregnant female between 18 and 70 years of age (inclusive) at Visit 1 (Screening).
The participant has a clinical diagnosis of isolated dystonia with symptoms consistent with 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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
VIM0423
DrugVIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
VIM0423 Placebo
DrugMatching VIM0423 placebo product containing no active ingredient
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Segmental/multifocal ActiveActive comparator 1 intervention
Group B: Segmental/multifocal PlaceboPlacebo comparator 1 intervention
Group C: Generalized ActiveActive comparator 1 intervention
Group D: Generalized PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
0-150, higher score worse
Time frame
From baseline to Week 14Secondary outcomes
1
Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician
1-7, higher score worse
Time frame
From baseline to Week 142
Change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale including head tremor (TWSTRS; as applicable)
0-85, higher score worse
Time frame
From baseline to Week 143
Clinical Global Impression of Change (CGI-C)
1-7, higher score worse
Time frame
From baseline to Week 144
Patient Global Impression of Change (PGI-C)
1-7, higher score worse
Time frame
From baseline to Week 14Other outcomes
1
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame
From baseline to Week 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov