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Trial · NCT02466386

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)SPD48986Participants
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Bedtime Resistance: Week 52/ET8.9Standard Deviation 3.04Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Sleep-onset Delay: Week 52/ET1.6Standard Deviation 0.67Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Sleep Duration: Week 52/ET3.8Standard Deviation 1.26Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Sleep Anxiety: Week 52/ET5.5Standard Deviation 2.09Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Night Wakings: Week 52/ET4.2Standard Deviation 1.59Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Parasomnias: Week 52/ET8.6Standard Deviation 1.54Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Sleep-disordered Breathing: Week 52/ET3.4Standard Deviation 0.74Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)SPD489Daytime Sleepiness: Week 52/ET10.1Standard Deviation 3.78Score on scale
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489Heart Rate (< 55 Beats per minute)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489Heart Rate (> 130 Beats per minute)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489PR Interval (>= 200 millisecond [msec])0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QRS Interval (>= 90 msec)3Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QT Interval (> = 440 msec)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QTcB Interval (> = 440 msec and < 480 msec)5Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QTcB Interval (>= 480 msec and < 500 msec)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QTcB Interval (>= 500 msec)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QTcF Interval (> = 440 msec and < 480 msec)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QTcF Interval (>= 480 msec and < 500 msec)0Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)SPD489QTcF Interval (>= 500 msec)0Participants

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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