Trial · NCT01332318
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) | Baseline (Day -1) and Day 16 | Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who completed at least one Baseline and one End of Study (Days 14-16) simulated driving assessment. The number of participants assessed at each study day varies due to incomplete/missing data. | feet | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV) | Baseline (Days -1 and 1) and Days 14 and 15 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | feet | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position | Baseline (Days -1 and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | feet | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability | Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | miles per hour | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed | Baseline (Days -1 and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | miles per hour | MEAN |
| SECONDARY | Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax) | Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time | Baseline (Days -1 and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | seconds | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score | Baseline (Days -1 and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. Varying numbers of participants did not complete either the pre- or post-drive VAS at either Baseline or the day of assessment; as such, the number of participants analyzed varies by day. | millimeters | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score | Baseline (Day -1) and Day 14 | Modified Intent-to-Treat (MITT) Population | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score | Baseline (Days -1 and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score | Baseline (Days -1and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS) | Baseline (Days -1and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score | Baseline (Days -1and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score | Baseline (Days -1 and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score | Baseline (Days -1and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score | Baseline (Days -1and 1) and Days 14, 15, and 16 | Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score | Baseline (Day -1) and Day 14 | Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. | scores on a scale | MEAN |
| SECONDARY | Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14 | Day 14 | Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. | participants | NUMBER |
| SECONDARY | Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14 | Day 14 | Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. | participants | NUMBER |
| SECONDARY | Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14 | Day 14 | Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. | participants | NUMBER |
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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