A Phase 3 interventional study of Esmirtazapine and Placebo in Insomnia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.
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 419 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 →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
Drug: Esmirtazapine
Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
Drug: Esmirtazapine
Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
Drug: Placebo
Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name corn starch), magnesium stearate, and lactose monohydrate.
Also known as: ORG 50081
The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.
Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.
Time frame: From Day 1 to Day 36
Average Latency to Persistent Sleep (LPS) During the In-Treatment Period
LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.
Time frame: From Day 1 to Day 36
Average Subjective Total Sleep Time (TST) During the In-Treatment Period
TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.
Time frame: From Day 1 to Day 36
| Milestone | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo |
|---|---|---|---|
| Started | 143 | 139 | 137 |
| All participants treated | 139 | 138 | 136 |
| Completed | 117 | 124 | 125 |
| Not completed | 26 | 15 | 12 |
| Withdrew: Other | 3 | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Lack of compliance | 1 | 0 | 0 |
| Withdrew: Reasons not related to trial | 4 | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 | 4 |
| Withdrew: Lack of efficacy | 0 | 2 | 0 |
| Withdrew: Adverse event | 11 | 5 | 2 |
| Withdrew: Randomized but not treated | 4 | 1 | 1 |
| Milestone | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo |
|---|---|---|---|
| Started | 139 | 138 | 136 |
| Completed | 139 | 138 | 136 |
| Not completed | 0 | 0 | 0 |
WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.
| Minutes | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo |
|---|---|---|---|
| Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period | 45.6 ± 25.7 | 45.5 ± 26.5 | 76.1 ± 46.0 |
LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.
| Minutes | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo |
|---|---|---|---|
| Average Latency to Persistent Sleep (LPS) During the In-Treatment Period | 28.7 ± 28.4 | 26.1 ± 23.0 | 40.5 ± 27.3 |
TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.
| Minutes | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo |
|---|---|---|---|
| Average Subjective Total Sleep Time (TST) During the In-Treatment Period | 384.6 ± 63.6 | 384.6 ± 66.2 | 351.6 ± 57.2 |
Collected over Day 1 to Day 50. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esmirtazapine 3.0 mg In-treatment | — | 0/139 (0%) | 20/139 (14.4%) |
| Esmirtazapine 4.5 mg In-treatment | — | 1/138 (0.7%) | 24/138 (17.4%) |
| Placebo In-treatment | — | 0/136 (0%) | 13/136 (9.6%) |
| Esmirtazapine 3.0 mg Follow-up | — | 0/139 (0%) | 2/139 (1.4%) |
| Esmirtazapine 4.5 mg Follow-up | — | 0/138 (0%) | 1/138 (0.7%) |
| Placebo Follow-up | — | 0/136 (0%) | 1/136 (0.7%) |
| Event | Esmirtazapine 3.0 mg In-treatment | Esmirtazapine 4.5 mg In-treatment | Placebo In-treatment | Esmirtazapine 3.0 mg Follow-up | Esmirtazapine 4.5 mg Follow-up | Placebo Follow-up |
|---|---|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 0/139 | 1/138 | 0/136 | 0/139 | 0/138 | 0/136 |
| Pneumonia streptococcalInfections and infestations | 0/139 | 1/138 | 0/136 | 0/139 | 0/138 | 0/136 |
| SepsisInfections and infestations | 0/139 | 1/138 | 0/136 | 0/139 | 0/138 | 0/136 |
| Event | Esmirtazapine 3.0 mg In-treatment | Esmirtazapine 4.5 mg In-treatment | Placebo In-treatment | Esmirtazapine 3.0 mg Follow-up | Esmirtazapine 4.5 mg Follow-up | Placebo Follow-up |
|---|---|---|---|---|---|---|
| SomnolenceNervous system disorders | 16/139 | 18/138 | 4/136 | 0/139 | 0/138 | 0/136 |
| HeadacheNervous system disorders | 5/139 | 7/138 | 9/136 | 2/139 | 1/138 | 1/136 |
| Age, Continuous(Years) | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 43.5 ± 11.3 | 44.5 ± 11.5 | 46.6 ± 10.5 | 44.9 ± 11.2 |
| Sex: Female, Male(Participants) | Esmirtazapine 3.0 mg | Esmirtazapine 4.5 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 98 | 89 | 90 | 277 |
| Male | 45 | 50 | 47 | 142 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Sep 2018. 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→
Merck Sharp & Dohme LLC