Trial · NCT00311363
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period | DB Treatment Period; Days 169 to 252 (Weeks 24 to 36) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | percentage of participants | NUMBER |
| SECONDARY | Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period | DB Treatment Period; Days 169 to 252 (Weeks 24 to 36) | DB ITT Population | ||
| SECONDARY | Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase) | DB Treatment Period; Days 184 to 252 (Weeks 26 to 36) | DB ITT Population | ||
| SECONDARY | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | points on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | participants | NUMBER |
| SECONDARY | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF | Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | points on a scale | MEAN |
| SECONDARY | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | points on a scale | MEAN |
| SECONDARY | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | points on a scale | MEAN |
| SECONDARY | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | hours | MEAN |
| SECONDARY | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | points on a scale | MEAN |
| SECONDARY | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population Participants who were missing severity scores for more than two 30-min windows during a 4-hour period had their maximum severity rating for the 4-hour period set to missing. At Randomization (Week 24), there was one participant in each arm with missing 24-hour RLS Record data. | participants | NUMBER |
| SECONDARY | Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase) | Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | hours | MEDIAN |
| SECONDARY | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description. | 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.
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