A Phase 2/3 interventional study of Eszopiclone 1 mg and Eszopiclone 2 mg in Primary Insomnia, sponsored by Eisai Co., Ltd.. Completed at 20 sites in Japan. Open to participants aged 21 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-02-04.
Sponsored by Eisai Co., Ltd. · Phase 2/3, Interventional, and Treatment
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 192 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:
Participants who meet both of the following based on polysomnogram (PSG) in observation period:
Exclusion Criteria:
Drug: Eszopiclone 1 mg
Drug: Eszopiclone 2 mg
Drug: Eszopiclone 3 mg
Drug: Placebo
Drug: Zolpidem Tartrate 10 mg
Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Also known as: SEP-190
Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Also known as: SEP-190
Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Also known as: SEP-190
Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Latency To Persistent Sleep (LPS)
The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Time frame: 10 days (5 intervals of two consecutive nights)
Sleep Latency (SL)
The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time frame: 10 days (5 intervals of two consecutive nights)
Total Sleep Time (Objective & Subjective)
Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time frame: 10 days (5 intervals of two consecutive nights)
Sleep Efficiency
Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours \* 100, expressed as a percent. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Time frame: 10 days (5 intervals of two consecutive nights)
Wake Time After Sleep Onset (WASO)- Objective & Subjective
Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time frame: 10 days (5 intervals of two consecutive nights)
Number of Awakenings (Objective & Subjective)
Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time frame: 10 days (5 intervals of two consecutive nights)
This study was recruited at 21 centers in Japan.
| Milestone | Entire Study Population |
|---|---|
| Started | 72 |
| Completed | 67 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Withdrawal by subject | 2 |
The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
| Minutes | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| Latency To Persistent Sleep (LPS) | 37.5 ± 37.8 | 24.4 ± 22.7 | 20.9 ± 24.3 | 12.8 ± 11.2 | 14.3 ± 22.6 |
Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
| Minutes | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| Objective Total Sleep Time | 414.0 (279.3 to 470.3) | 438.3 (292.3 to 468.5) | 452.5 (227.5 to 475.8) | 453.4 (313.5 to 474.5) | 448.6 (338.8 to 476.3) |
| Subjective Total Sleep Time | 360.0 (90.0 to 452.5) | 390.0 (225.0 to 460.0) | 397.5 (225.0 to 478.5) | 420.0 (225.0 to 480.0) | 411.3 (195.0 to 480.0) |
Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours \* 100, expressed as a percent. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
| Percentage of time asleep of 8 hours | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| Sleep Efficiency | 86.3 (58.2 to 98.0) | 91.3 (60.9 to 97.6) | 94.3 (47.4 to 99.2) | 94.5 (65.3 to 98.9) | 93.5 (70.6 to 99.3) |
Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
| Minutes | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| Objective Wake Time After Sleep Onset | 26.3 (1.5 to 164.3) | 22.5 (1.0 to 144.8) | 17.8 (0.5 to 176.0) | 18.8 (0.8 to 165.5) | 20.0 (1.5 to 139.5) |
| Subjective Wake Time After Sleep Onset | 75.0 (3.0 to 300.0) | 60.0 (0.5 to 285.0) | 37.5 (0.0 to 255.0) | 40.0 (0.0 to 227.5) | 50.0 (0.0 to 285.0) |
Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
| Number of awakenings | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| Objective Number of Awakenings | 4.0 (0.5 to 18.0) | 4.0 (0.0 to 11.0) | 3.5 (0.0 to 10.0) | 2.8 (0.0 to 10.0) | 3.5 (0.5 to 14.0) |
| Subjective Number of Awakenings | 3.0 (0.0 to 11.0) | 3.0 (0.5 to 8.0) | 2.5 (0.0 to 6.5) | 2.0 (0.0 to 8.0) | 2.0 (0.0 to 6.0) |
The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
| Minutes | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| Sleep Latency (SL) | 62.0 ± 47.8 | 45.5 ± 36.7 | 32.6 ± 26.4 | 28.4 ± 23.8 | 28.0 ± 24.6 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/71 (0%) | 5/71 (7%) |
| Eszopiclone 1 mg | — | 0/70 (0%) | 10/70 (14.3%) |
| Eszopiclone 2 mg | — | 0/69 (0%) | 10/69 (14.5%) |
| Eszopiclone 3 mg | — | 0/68 (0%) | 17/68 (25%) |
| Zolpidem Tartrate 10 mg | — | 0/70 (0%) | 8/70 (11.4%) |
| Event | Placebo | Eszopiclone 1 mg | Eszopiclone 2 mg | Eszopiclone 3 mg | Zolpidem Tartrate 10 mg |
|---|---|---|---|---|---|
| DysgeusiaNervous system disorders | 1/71 | 4/70 | 6/69 | 11/68 | 1/70 |
| SomnolenceNervous system disorders | 2/71 | 1/70 | 3/69 | 4/68 | 3/70 |
| DizzinessNervous system disorders | 0/71 | 0/70 | 0/69 | 2/68 | 3/70 |
| Feeling AbnormalGeneral disorders | 0/71 | 3/70 | 0/69 | 0/68 | 0/70 |
| Dermatitis ContactSkin and subcutaneous tissue disorders | 2/71 | 2/70 | 1/69 | 0/68 | 1/70 |
| Age Continuous(years) | Entire Study Population |
|---|---|
| Mean | 39.4 ± 11.9 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 29 |
| Male | 43 |
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
Eisai Co., Ltd.