A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

NCT00506389 | Completed Phase 3 Results

• 2 other identifiers: P05707176002
• Study Type: interventional
• Target: 419
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Insomnia

Keywords

Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  From Day 1 to Day 36

Secondary Outcomes (2)

• Average Latency to Persistent Sleep (LPS) During the In-Treatment Period

  From Day 1 to Day 36

• Average Subjective Total Sleep Time (TST) During the In-Treatment Period

  From Day 1 to Day 36

Study Arms (3)

Esmirtazapine 3.0 mg

EXPERIMENTAL

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

Esmirtazapine 4.5 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Esmirtazapine DRUG

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

Esmirtazapine 3.0 mg; Esmirtazapine 4.5 mg

Placebo DRUG

The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of chronic primary insomnia

You may not qualify if:

• Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
• Has significant medical or psychiatric illness as causing the sleep disorder
• Diagnosed with major depressive disorder
• Substance abuse within the past year
• Night worker or work on rotating shifts
• Has had serious head injury, stroke, epilepsy
• Has a history of bipolar disorder or family (immediate family) history of suicide
• Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
• Drinks beverages containing more than 500 mg caffeine per day

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Parexel: collaborator

Related Publications (1)

• Ivgy-May N, Ruwe F, Krystal A, Roth T. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial. Sleep Med. 2015 Jul;16(7):838-44. doi: 10.1016/j.sleep.2015.04.001. Epub 2015 Apr 16.

  PMID: 26047892 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development Group Leader
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: June 6, 2007
• Primary Completion: February 13, 2008
• Study Completion: February 13, 2008
• Last Updated: October 2, 2018
• Results First Posted: August 6, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share