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NCT07140913

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 22 versions: 22 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 104 → 109 locations
    • Interventions: Placebo (Drug), Xanomeline/Trospium Chloride (Drug) to Placebo (Drug), Xanomeline/Trospium Chloride (Drug)
    • Eligibility criteria expanded, about 15 words
  2. Study sites: 103 to 104v21
  3. Study sites: 105 to 103v20
  4. Study sites: 103 to 105v19
  5. Study sites: 102 to 103v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 103 to 102v17
  2. Study sites: 101 to 103
    • Interventions: Lamotrigine (Drug), Lithium (Drug), Placebo (Drug), Valproate (Drug), Xanomeline/Trospium Chloride (Drug) to Placebo (Drug), Xanomeline/Trospium Chloride (Drug)
    • Eligibility criteria expanded, about 21 words
    v16
  3. Study sites revised (101)v15
  4. Study sites: 102 to 101v14
  5. Study sites: 91 to 102v13
  6. Study sites revised (91)v12
  7. Study sites: 90 to 91v11
  8. Study sites revised (90)v10
  9. Study sites: 88 to 90v9
  10. Study sites: 84 to 88v8
  11. Study sites revised (84)v7
  12. Study sites: 82 to 84v6
  13. Study sites revised (82)v5
  14. Study sites: 66 to 82v4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 41 to 66
    • Start date changed from estimate of Sep 5, 2025 to Oct 8, 2025
    v3
  16. Study sites: 32 to 41v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
Timeframe: At Week 5

Secondary (11)

Change from baseline in Clinical Global Impressions Bipolar (CGI-BP) at Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 50% decrease from baseline in Young Mania Rating Scale (YMRS) score
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 1 change from baseline in CGI-BP
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Number of participants with Serious Adverse Events (SAEs)
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Number of participants with TEAEs leading to treatment discontinuation
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Change from baseline in Barnes Akathisia Rating Scale (BARS) at Week 5
Change from baseline in Simpson Angus Scale (SAS) at Week 5
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) at Week 5
Change from baseline in International Prostate Symptom Score (IPSS) at Week 5

Arms and interventions

KarXT + Lithium, Valproate, or LamotrigineExperimental
Placebo + Lithium, Valproate, or LamotriginePlacebo comparator

Drugs: Xanomeline/Trospium Chloride, Placebo

Sites

109 sites in 13 countries

United States 22, Japan 14, Ukraine 12, China 11, Romania 11, Argentina 6, Bulgaria 5, France 5, India 5, Israel 5, Italy 5, Poland 5, Denmark 3