Trial · NCT00608985
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
NCT00608985, Phase 3, Completed, Midnight Pharma, LLC; results first posted 2013-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia. Trials, record NCT00608985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608985
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
- NCT number
- NCT00608985
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 709 participants, actual
- Lead sponsor
- Midnight Pharma, LLC
- Conditions
- Primary Insomnia
- Interventions
- almorexant, almorexant, Placebo, zolpidem
- First posted
- 2008-02-06
- Last updated
- 2016-03-14
- Results first posted
- 2013-02-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | From baseline to Day 1&2 | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16 |
| Primary | Change From Baseline to Day 15&16 in WASO | From baseline to Day 15&16 | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16 |
| Primary | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | From baseline to Week 1&2 | sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1\&2 |
| Secondary | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | From baseline to Day 1&2 | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG |
| Secondary | Change From Baseline to Day 15&16 in LPS | From baseline to Day 15&16 | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG |
| Secondary | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | From baseline to Week 1&2 | sLSO was the self-reported time to fall asleep as reported in the sleep diary |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | From baseline to Day 1&2 | All treated patients | minutes | MEDIAN |
| PRIMARY | Change From Baseline to Day 15&16 in WASO | From baseline to Day 15&16 | All treated patients | minutes | MEDIAN |
| PRIMARY | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | From baseline to Week 1&2 | All treated patients with available data | minutes | MEDIAN |
| SECONDARY | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | From baseline to Day 1&2 | All treated patients | minutes | MEDIAN |
| SECONDARY | Change From Baseline to Day 15&16 in LPS | From baseline to Day 15&16 | All treated patients | minutes | MEDIAN |
| SECONDARY | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | From baseline to Week 1&2 | All treated patients with available data | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Placebo | Baseline | 85.0 | 95% Confidence Interval 39.81 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Almorexant 100mg | Baseline | 86.6 | 95% Confidence Interval 39.17 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Almorexant 200mg | Baseline | 92.3 | 95% Confidence Interval 35.92 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Zolpidem 10mg | Baseline | 76.5 | 95% Confidence Interval 36.95 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Placebo | Day 1&2 | 72.8 | 95% Confidence Interval 42.63 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Almorexant 100mg | Day 1&2 | 54.5 | 95% Confidence Interval 37.65 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Almorexant 200mg | Day 1&2 | 46.4 | 95% Confidence Interval 28.85 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Zolpidem 10mg | Day 1&2 | 54.6 | 95% Confidence Interval 36.05 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Placebo | Change from baseline to day 1&2 | -11.8 | 95% Confidence Interval 38.73 | minutes |
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Almorexant 100mg | Change from baseline to day 1&2 | -29.0 | 95% Confidence Interval 31.50 | minutes |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 177 | |
| Overall Study | STARTED | Almorexant 100mg | 186 | |
| Overall Study | STARTED | Almorexant 200mg | 176 | |
| Overall Study | STARTED | Zolpidem 10mg | 168 | |
| Overall Study | Completed Double-blind Treatment | Placebo | 163 | |
| Overall Study | Completed Double-blind Treatment | Almorexant 100mg | 174 | |
| Overall Study | Completed Double-blind Treatment | Almorexant 200mg | 171 | |
| Overall Study | Completed Double-blind Treatment | Zolpidem 10mg | 161 | |
| Overall Study | COMPLETED | Placebo | 161 | |
| Overall Study | COMPLETED | Almorexant 100mg | 173 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events140
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 | HEADACHE | Nervous system disorders | Placebo | 21 | 177 | |
| other | HEADACHE | Nervous system disorders | Almorexant 100mg | 18 | 186 | |
| other | HEADACHE | Nervous system disorders | Almorexant 200mg | 26 | 176 | |
| other | HEADACHE | Nervous system disorders | Zolpidem 10mg | 29 | 168 | |
| other | FATIGUE | General disorders | Placebo | 2 | 177 | |
| other | FATIGUE | General disorders | Almorexant 100mg | 9 | 186 | |
| other | FATIGUE | General disorders | Almorexant 200mg | 6 | 176 | |
| other | FATIGUE | General disorders | Zolpidem 10mg | 6 | 168 | |
| other | DIZZINESS | Nervous system disorders | Placebo | 10 | 177 | |
| other | DIZZINESS | Nervous system disorders | Almorexant 100mg | 6 | 186 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Almorexant 100mg | ||
| Total, all-cause mortality | Almorexant 200mg | ||
| Total, all-cause mortality | Zolpidem 10mg | ||
| Total, other adverse events | Placebo | 64 | 177 |
| Total, other adverse events | Almorexant 100mg | 65 | 186 |
| Total, other adverse events | Almorexant 200mg | 61 | 176 |
| Total, other adverse events | Zolpidem 10mg | 72 | 168 |
| Total, serious adverse events | Placebo | 0 | 177 |
| Total, serious adverse events | Almorexant 100mg | 2 | 186 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28735928 | DERIVED |
Source PubMed
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT00608985
GET https://conductscience.org/api/trials/v1/NCT00608985/results?page=2