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Trial · NCT01718509

Outcomes20

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12Baseline and Visit 8 Which Spans Weeks 11/12
The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).
Binge days per weekLEAST_SQUARES_MEAN
SECONDARYPercent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) ScoresUp to 12 weeksFull Analysis Setpercentage of participantsNUMBER
SECONDARYPercent of Participants With a 4-Week Cessation From Binge EatingUp to 12 weeksFull Analysis Setpercentage of participantsNUMBER
SECONDARYPercent Change From Baseline in Body Weight (kg) at Week 12Baseline and week 12Full Analysis Set.percentage changeLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12Baseline and week 12Full Analysis Set.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Fasting Triglyceride Levels at Up to 12 WeeksBaseline and up to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.mmol/LLEAST_SQUARES_MEAN
SECONDARYChange From Baseline In Fasting Total Cholesterol Levels at Up to 12 WeeksBaseline and up to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.mmol/LLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Hemoglobin A1c Levels at Up to 12 WeeksBaseline and up to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.PercentLEAST_SQUARES_MEAN
SECONDARYBinge Eating ResponseUp to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.percentage of participantsNUMBER
SECONDARYChange From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12Baseline and Visit 8 Which Spans Weeks 11/12Full Analysis Set.Binge episodes per weekLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Eating Inventory Scores at Week 12Baseline and week 12Full Analysis Set.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Binge Eating Scale (BES) Score at Week 12Baseline and week 12Full Analysis Set.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 WeeksBaseline and up to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.t-scoresLEAST_SQUARES_MEAN
SECONDARYEuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): MobilityUp to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.percentage of participantsNUMBER
SECONDARYEuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-CareUp to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.percentage of participantsNUMBER
SECONDARYEuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual ActivitiesUp to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.percentage of participantsNUMBER
SECONDARYEuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/DiscomfortUp to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.percentage of participantsNUMBER
SECONDARYEuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/DepressionUp to 12 weeksFull Analysis Set. Not all subjects had data for this outcome.percentage of participantsNUMBER
SECONDARYColumbia-Suicide Severity Rating Scale (C-SSRS)Up to 12 weeks
For this Outcome Measure the Safety Analysis Set is defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed, and responded to the relevant questions for the C-SSRS. All subjects from Site 015 were excluded from the Safety Analysis Set.
participantsNUMBER
SECONDARYChange in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.Baseline and Week 12Safety Analysis Set who completed ACSC at Baseline \& Week 12 Visits.units on a scaleMEAN

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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