A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

NCT00631657 | Completed Phase 3 Results

• 3 other identifiers: P05701211062007-005236-92
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

Conditions

Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorder, Intrinsic

Keywords

placebo controlled; randomized; double blind

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period

  TST was defined as the time recorded for sleep diary question 6 "How much time did you actually spend sleeping?" as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach.

  Baseline and the Mean of Weeks 14-26

Secondary Outcomes (4)

• Number of Participants Who Experienced Adverse Events (AEs)

  Up to 31 weeks

• Number of Participants Who Discontinued Study Drug Due to an AE

  Up to 27 weeks

• Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period

  Baseline and the Mean of Weeks 14-26

• Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period

  Baseline and the Mean of Weeks 14-26

Other Outcomes (6)

• Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period

  Baseline and the Mean of Weeks 14-26

• Change From Baseline in Sleep Quality - 6-Month Treatment Period

  Baseline and the Mean of Weeks 14-26

• Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period

  Baseline and the Mean of Weeks 14-26

Study Arms (2)

Esmirtazapine 4.5 mg

EXPERIMENTAL

Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months

Drug: Esmirtazapine

Placebo

PLACEBO COMPARATOR

Participants receive placebo tablets, administered once a day for 6 months

Drug: Placebo

Interventions

Esmirtazapine DRUG

One esmirtazapine 4.5 mg tablet once a day

Esmirtazapine 4.5 mg

Placebo DRUG

One placebo tablet once a day

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:

• are at least 18 and less than 65 years;
• sign written informed consent after the scope and nature of the investigation have been explained;
• have shown capability to complete the LogPad questionnaires;
• have difficulty falling asleep, maintaining sleep or have early morning awakening;

You may not qualify if:

• Significant medical or psychiatric illness causing sleep disturbances.
• Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
• Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
• Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
• Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
• Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
• Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
• Routinely nap during the day.
• Have a Body Mass Index (BMI) of 36 or more.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.

  PMID: 32351205 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Wake Disorders; Sleep Disorders, Intrinsic

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Nervous System Diseases; 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
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: March 4, 2008
• Primary Completion: November 19, 2009
• Study Completion: November 19, 2009
• Last Updated: October 2, 2018
• Results First Posted: August 1, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share