Trial · NCT01463098
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
NCT01463098, Phase 1, Completed, Eisai Inc.; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006. Trials, record NCT01463098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01463098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
- NCT number
- NCT01463098
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 122 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Insomnia
- Interventions
E2006 1.0 mg, E2006 2.5 mg, E2006 5.0 mg, E2006 10.0 mg, E2006 25.0 mg, E2006 50.0 mg, E2006 100 mg, E2006 200 mg, Zolpidem 10 mg, E2006 Matched Placebo or Zolpidem Matched Placebo, E2006 Matched Placebo
- First posted
- 2011-11-01
- Last updated
- 2020-01-18
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Baseline up to Day 11 | |
| Primary | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | Baseline up to Day 6 | |
| Primary | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | Baseline up to Day 11 | |
| Primary | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | Baseline up to Day 11 | |
| Primary | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Day 11 | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure. |
| Primary | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline, Day 1 | LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG. |
| Primary | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline, Day 1 | TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed. |
| Primary | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline, Day 1 | Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed. |
| Primary | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline, Day 1 | WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on. |
| Primary | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline, Day 1 | Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs. |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Baseline up to Day 11 | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | Baseline up to Day 6 | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | Baseline up to Day 11 | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | Baseline up to Day 11 | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Day 11 | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline, Day 1 | Pharmacodynamic (PD) analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | minutes | MEAN |
| PRIMARY | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline, Day 1 | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | minutes | MEAN |
| PRIMARY | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline, Day 1 | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | percentage of time asleep | MEAN |
| PRIMARY | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline, Day 1 | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | minutes | MEAN |
| PRIMARY | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline, Day 1 | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | awakenings | MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group533
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 Matched Placebo | AEs | 7 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 1.0 mg | AEs | 1 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 2.5 mg | AEs | 0 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 5 mg | AEs | 1 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 10 mg | AEs | 4 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 25 mg | AEs | 2 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 50 mg | AEs | 4 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 100 mg | AEs | 2 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 200 mg | AEs | 5 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Part A: E2006 Matched Placebo | SAEs | 0 | Participants |
1 to 10 of 533Source ClinicalTrials.gov
See all 533 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (11 Days) | STARTED | Part A: E2006 Matched Placebo | 16 | |
| Part A (11 Days) | STARTED | Part A: E2006 1.0 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 2.5 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 5 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 10 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 25 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 50 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 100 mg | 6 | |
| Part A (11 Days) | STARTED | Part A: E2006 200 mg | 6 | |
| Part A (11 Days) | STARTED | Part B: E2006 Matched Placebo or Zolpidem Matched Placebo | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events560
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 | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 Matched Placebo | 0 | 16 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 1.0 mg | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 2.5 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 5 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 10 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 25 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 50 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 100 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part A: E2006 200 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Part B: E2006 Matched Placebo or Zolpidem Matched Placebo | 0 | 12 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: E2006 Matched Placebo | 0 | 16 |
| Total, all-cause mortality | Part A: E2006 1.0 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 2.5 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 5 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 10 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 25 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 50 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 100 mg | 0 | 6 |
| Total, all-cause mortality | Part A: E2006 200 mg | 0 | 6 |
| Total, all-cause mortality | Part B: E2006 Matched Placebo or Zolpidem Matched Placebo | 0 | 12 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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.
Tests2
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 |
|---|---|---|
| Psychomotor Vigilance Task | Primary outcome | ConductCognition |
| Symbol Coding | Primary 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/NCT01463098
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