Trial · NCT01718483
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12) | Baseline and Visit 8 (Weeks 11-12) | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). | Binge days per week | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a 4-Week Cessation From Binge Eating | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Body Weight at Week 12 | Baseline and Week 12 | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | Baseline and Week 12 | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | Baseline and Week 12/Early termination (ET) | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | millimole per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | Baseline and Week 12/ET | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | Baseline and Week 12/ET | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | Percent hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Binge Eating Response | Week 12/ET | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12) | Baseline and Visit 8 (Weeks 11-12) | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). | Binge episodes per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eating Inventory Scores at Week 12 | Baseline and Week 12 | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Binge Eating Scale (BES) Score at Week 12 | Baseline and Week 12 | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12 | Baseline and Week 12 | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | t-scores | LEAST_SQUARES_MEAN |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Up to 12 weeks | The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 12 weeks | The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome. | participants | NUMBER |
| SECONDARY | Amphetamine Cessation Symptom Assessment (ACSA) Total Score | Up to 12 weeks | The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome. | units on a scale | MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01718483/outcomes