Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

Study Overview
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Brief Summary
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The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Official Title
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A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Esmirtazapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has signed written informed consent after the scope and nature of the investigation was explained to them Has difficulty falling asleep, maintaining sleep or has early morning awakenings Exclusion Criteria: Significant medical or psychiatric illness causing sleep disturbances Has a history of bipolar disorder or family (immediate family) of suicide Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esmirtazapine 1.5 mg<br>Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks | Drug: Esmirtazapine<br>* Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, 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. Tablets were administered orally once daily about 30 minutes prior to bedtime.<br>* Other names: MK-8265;|
| Experimental: Esmirtazapine 3.0 mg<br>Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks | Drug: Esmirtazapine<br>* Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, 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. Tablets were administered orally once daily about 30 minutes prior to bedtime.<br>* Other names: MK-8265;|
| Experimental: Esmirtazapine 4.5 mg<br>Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks | Drug: Esmirtazapine<br>* Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, 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. Tablets were administered orally once daily about 30 minutes prior to bedtime.<br>* Other names: MK-8265;|
| Placebo Comparator: Placebo<br>Placebo to esmirtazapine | Drug: Placebo<br>* Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period | TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active 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 present was used in the analysis. | Day 1 to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period | SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis. | Day 1 to Day 15 | 
| Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period | The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Day 1 to Day 15 | 
| Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period | The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Day 1 to Day 15 |