An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients

Part of paid clinical trials in Richmond, Texas.

Sponsor
Vanguard Research Group
Study ID
NCT06923891
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Xanomeline/Trospium — DRUG
    Xanomeline/Trospium (titrated dose)

Study Details

This is an open label study of the treatment satisfaction, efficacy and tolerability of xanomeline/ trospium in a population of 172 participants diagnosed with schizophrenia in the early phase of illness. Participants will be followed for 24 weeks with scheduled assessments conducted by centralized raters, local mental health professionals and self-assessments completed by patients. Recruitment will be based on insufficient efficacy of previous antipsychotic or due to dissatisfaction with treatment as a result of unacceptable side effects on previous antipsychotic/patient choice, with approximately 50% for each enrollment criteria. Participants who present with both insufficient efficacy and unacceptable side effects will be considered as belonging to the insufficient efficacy subgroup. Treatment and assessments will be identical for the 2 groups. Primary outcome for participants enrolled will be improvement in overall treatment satisfaction as measured by the MSQ.

Key Dates

Start date
Apr 16, 2025
Status verified
Apr 2025
Primary completion
Oct 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
172 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Xanomeline/Trospium
    Cobenfy

Primary Outcome Measure

Medication Satisfaction Questionnaire (MSQ) [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical SiteRichmondTexas77407

Find similar trials in Richmond, TX

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Clinical Site· Richmond, TX

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