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Trial · NCT04745026

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total ScoresBaseline up to Week 12Aberrant behavior checklist subscale total scores were assessed in participants with available data in the Full Analysis Set.score on a scaleMEAN
PRIMARYChange From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) ScoresBaseline up to Week 12Vineland Adaptive Behavior Scales-3 (VABS-3) scores were assessed in participants with available data in the Full Analysis Set.score on a scaleMEAN
PRIMARYNumber of Patients Per Clinical Global Impression Improvement (CGI-I) CategoryDay 85Patients per CGI-I category were assessed in participants with available data in the Full Analysis Set.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYChange From Baseline in Clinical Global Impression Severity (CGI-S) ScoresBaseline up to Week 12CGI-S was assessed in participants with available data in the Full Analysis Set.score on a scaleMEAN
SECONDARYNumber of Participants Reporting Treatment-emergent Adverse EventsBaseline up to Week 12Adverse events were assessed in the Safety Analysis Set.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMean Change From Baseline in Hematology Clinical Laboratory LevelsBaseline up to Week 9 (end of taper/withdrawal)Hematology clinical laboratory levels were assessed in participants with available data in the Safety Analysis Set.10^9 cells/LMEAN
SECONDARYMean Percentage Change From Baseline in Hematology Clinical Laboratory LevelsBaseline up to Week 9 (end of taper/withdrawal)Hematology clinical laboratory levels were assessed in participants with available data in the Safety Analysis Set.percentage change from baselineMEAN
SECONDARYMean Change From Baseline in Hemoglobin LevelsWeek 9 (end of taper/withdrawal)Hemoglobin levels were assessed in participants with available data in the Safety Analysis Set.g/dLMEAN
SECONDARYMean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin LevelsWeek 9 (end of taper/withdrawal)Erythrocyte mean corpuscular hemoglobin levels were assessed in participants with available data in the Safety Analysis Set.pg/cellMEAN
SECONDARYMean Change From Baseline in Erythrocyte Mean Corpuscular Volume LevelsWeek 9 (end of taper/withdrawal)Erythrocyte mean corpuscular volume levels were assessed in participants with available data in the Safety Analysis Set.fLMEAN
SECONDARYNumber of Patients With Clinically Significant Vital Sign ValuesPost-baseline up to 12 weeksVital signs were assessed in participants with available data in the Safety Analysis Set.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients With Clinically Significant Physical Examination Procedure FindingsBaseline up to Day 85 post-baselineAbnormal physical exam findings were assessed in participants with available data in the Safety Analysis Set.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients With Clinically Significant 12-lead Electrocardiogram FindingsBaseline up to Day 85 post-baselineClinically significant 12-lead electrocardiogram were assessed in participants with available data in the Safety Analysis Set.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)Baseline up to Day 92Suicidal ideation or behavior was assessed in participants with available data in the Safety Analysis Set.ParticipantsCOUNT_OF_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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