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Trial · NCT06937229

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)Up to approximately Week 30
SecondaryNumber of Participants With Adverse Events (AEs)Up to approximately Week 30
SecondaryNumber of Participants With Serious AEs (SAEs)Up to approximately Week 30
SecondaryNumber of Participants With TEAEs Leading to Study WithdrawalUp to approximately Week 30
SecondaryNumber of Participants With TEAEs Leading to DeathUp to approximately Week 30
SecondaryNumber of Participants with Adverse Events of Special Interest (AESI)Up to approximately Week 30
SecondaryChange From Baseline in Barnes Akathisia Rating Scale (BARS)Up to approximately Week 26
SecondaryChange From Baseline in Abnormal Involuntary Movement Scale (AIMS)Up to approximately Week 26
SecondaryChange From Baseline in Body WeightUp to approximately Week 26
SecondaryChange From Baseline in Body Mass Index (BMI)Up to approximately Week 26
SecondaryNumber of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)Up to approximately Week 30This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.
SecondaryNumber of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)Up to approximately Week 30This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.
SecondaryNumber of Participants With Clinically Significant Changes in Laboratory EvaluationsUp to approximately Week 30
SecondaryNumber of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)Up to approximately Week 26
SecondaryNumber of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)Up to approximately Week 30
SecondaryNumber of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)Up to approximately Week 26
SecondaryNumber of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)Up to approximately Week 26
SecondaryChange From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)Up to approximately Week 26This analysis is done in male participants.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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