Trial · NCT00748098
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 | Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF) | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | limb movements per hour | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | number of PLMs/total hours of sleep | LEAST_SQUARES_MEAN |
| SECONDARY | Number of PLMAI Responders at Week 4/10 Using LOCF | Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: The number of participants assessed varied due to missing/incomplete diary data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF. | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: The number of participants assessed varied due to missing/incomplete diary data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: The number of participants assessed varied due to missing/incomplete diary data. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF | Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: The number of participants assessed varied due to missing/incomplete diary data. | participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_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.
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