Trial · NCT03001557
Outcomes53
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 53
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Baseline, Week 1 | The full analysis set (FAS) included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment | Baseline, Week 1 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment | Baseline, Week 1 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | minutes | MEAN |
| PRIMARY | Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | minutes | MEAN |
| PRIMARY | Core Phase: Change From Baseline in the aMeanDurWB During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | minutes | MEAN |
| PRIMARY | Core Phase: Change From Baseline in the aMeanDurWB During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | minutes | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment | Baseline, Week 1 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of wake time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aWE During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of wake time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aWE During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of wake time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aWE During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of wake time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment | Baseline, Week 1 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean WFI During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean WFI During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean WFI During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | 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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