Trial · NCT01332318
Simulated Driving Study in Restless Legs Syndrome
NCT01332318, Phase 2, Completed, XenoPort, Inc.; results first posted 2011-06-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Simulated Driving Study in Restless Legs Syndrome. Trials, record NCT01332318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01332318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Simulated Driving Study in Restless Legs Syndrome
- NCT number
- NCT01332318
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- XenoPort, Inc.
- Conditions
- Restless Legs Syndrome
- Interventions
- XP13512, Diphenhydramine, Placebo
- First posted
- 2011-04-11
- Last updated
- 2013-07-26
- Results first posted
- 2011-06-28
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) | Baseline (Day -1) and Day 16 | Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH. |
| 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 | Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 14 (in the evening) or Day 15 (in the morning after GEn dosed at 5 PM) mean LPV over the 1-hour drive minus the Baseline (Day -1 or Day 1) mean LPV over the 1-hour drive. |
| 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 | Lane position was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall average lane position was calculated as the Day 14 (in the evening), 15 (in the morning after GEn dosed at 5 PM), or 16 (assessment at Tmax of GEn and DPH) mean lane position over the 1-hour drive minus the Baseline (Days -1 and 1) mean lane position over the 1-hour drive. |
| 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 | Speed variability was defined as the standard deviation of the speed (measured in miles per hour). Participants were instructed to maintain a speed of 55 miles per hour during the test drive. Change from baseline in overall speed variability was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed variability over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed variability over the 1-hour drive. |
| 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 | Participants were instructed to maintain a speed of 55 miles per hour during the driving assessment. Change from baseline in overall average speed was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed over the 1-hour drive. |
| 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 | A simulated crash was defined as a collision with an oncoming car or obstacle (e.g., tree) or when the distance to the center line was greater than 18 feet on either side of the road. |
| 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 | Brake reaction time was assessed as the time it took for each participant to move their foot off the accelerator and onto the brake pedal after the appearance of a stop sign on the simulation screen. Change from baseline was calculated as the Day 14, 15, or 16 mean reaction time minus the Baseline (Days -1 and 1) mean reaction time. |
| 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 | Alertness VAS was completed immediately before and after each simulated driving assessment. Participants indicated their alertness by marking a vertical line on a horizontal scale anchored by responses "extremely sleepy" and "extremely alert." VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point the participant marked. Scores ranged from 0-100 mm, with higher scores indicating more alertness and lower scores indicating more sleepiness. Change score was calculated as the Day 14, 15, or 16 VAS score minus the Baseline VAS score. |
| Secondary | Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score | Baseline (Day -1) and Day 14 | The Epworth Sleepiness Scale (ESS) is a questionnaire designed to evaluate daytime sleepiness. Participants were asked to rate how likely they were to doze or fall asleep during 8 activities on a scale of 0 ("would never do") to 3 ("high chance of dozing"). The total score ranges from 0-24, with a score greater than 10 representing excessive daytime sleepiness (an increased chance of dozing). Change from baseline was calculated as the Day 14 total score minus the Baseline total score. |
| 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 | The BAC was designed as a comprehensive measure of cognitive function, including 6 individual tests: Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London. The composite/total BAC score is calculated by scoring each individual test, comparing each score to a healthy control sample (matched for sex and age category) to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group425
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) | GEn Placebo and DPH Placebo | -0.10 | Standard Error 0.06 | feet | |
| Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) | GEn 1200 mg and DPH Placebo | 0.15 | Standard Error 0.06 | feet | |
| Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) | GEn 1800 mg and DPH Placebo | 0.15 | Standard Error 0.06 | feet | |
| Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) | GEn Placebo and DPH 50 mg on Day 16 | 0.16 | Standard Error 0.06 | feet | |
| 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) | GEn Placebo and DPH Placebo | Day 14, n=33, 28, 33, 28 | -0.06 | Standard Deviation 0.17 | feet |
| 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) | GEn 1200 mg and DPH Placebo | Day 14, n=33, 28, 33, 28 | 0.17 | Standard Deviation 0.43 | feet |
| 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) | GEn 1800 mg and DPH Placebo | Day 14, n=33, 28, 33, 28 | -0.01 | Standard Deviation 0.28 | feet |
| 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) | GEn Placebo and DPH 50 mg on Day 16 | Day 14, n=33, 28, 33, 28 | -0.08 | Standard Deviation 0.15 | feet |
| 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) | GEn Placebo and DPH Placebo | Day 15, n=32, 28, 31, 27 | -0.01 | Standard Deviation 0.14 | feet |
| 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) | GEn 1200 mg and DPH Placebo | Day 15, n=32, 28, 31, 27 | 0.13 | Standard Deviation 0.40 | feet |
1 to 10 of 425Source ClinicalTrials.gov
See all 425 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GEn Placebo and DPH Placebo | 34 | |
| Overall Study | STARTED | GEn 1200 mg and DPH Placebo | 32 | |
| Overall Study | STARTED | GEn 1800 mg and DPH Placebo | 34 | |
| Overall Study | STARTED | GEn Placebo and DPH 50 mg on Day 16 | 30 | |
| Overall Study | COMPLETED | GEn Placebo and DPH Placebo | 32 | |
| Overall Study | COMPLETED | GEn 1200 mg and DPH Placebo | 28 | |
| Overall Study | COMPLETED | GEn 1800 mg and DPH Placebo | 33 | |
| Overall Study | COMPLETED | GEn Placebo and DPH 50 mg on Day 16 | 28 | |
| Overall Study | NOT COMPLETED | GEn Placebo and DPH Placebo | 2 | |
| Overall Study | NOT COMPLETED | GEn 1200 mg and DPH Placebo | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | GEn Placebo and DPH Placebo | 1 | 34 | |
| other | Somnolence | Nervous system disorders | GEn 1200 mg and DPH Placebo | 8 | 31 | |
| other | Somnolence | Nervous system disorders | GEn 1800 mg and DPH Placebo | 13 | 34 | |
| other | Somnolence | Nervous system disorders | GEn Placebo and DPH 50 mg on Day 16 | 2 | 30 | |
| other | Headache | Nervous system disorders | GEn Placebo and DPH Placebo | 3 | 34 | |
| other | Headache | Nervous system disorders | GEn 1200 mg and DPH Placebo | 5 | 31 | |
| other | Headache | Nervous system disorders | GEn 1800 mg and DPH Placebo | 4 | 34 | |
| other | Headache | Nervous system disorders | GEn Placebo and DPH 50 mg on Day 16 | 4 | 30 | |
| other | Dizziness | Nervous system disorders | GEn Placebo and DPH Placebo | 3 | 34 | |
| other | Dizziness | Nervous system disorders | GEn 1200 mg and DPH Placebo | 4 | 31 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GEn Placebo and DPH Placebo | ||
| Total, all-cause mortality | GEn 1200 mg and DPH Placebo | ||
| Total, all-cause mortality | GEn 1800 mg and DPH Placebo | ||
| Total, all-cause mortality | GEn Placebo and DPH 50 mg on Day 16 | ||
| Total, other adverse events | GEn Placebo and DPH Placebo | 10 | 34 |
| Total, other adverse events | GEn 1200 mg and DPH Placebo | 16 | 31 |
| Total, other adverse events | GEn 1800 mg and DPH Placebo | 21 | 34 |
| Total, other adverse events | GEn Placebo and DPH 50 mg on Day 16 | 11 | 30 |
| Total, serious adverse events | GEn Placebo and DPH Placebo | 0 | 34 |
| Total, serious adverse events | GEn 1200 mg and DPH Placebo | 0 | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Tower Planning | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01332318
GET https://conductscience.org/api/trials/v1/NCT01332318/registered?page=2