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

NCT ID: NCT00631657

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-04
• Study Completion Date: 2009-11-19

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).

Detailed Description

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.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Esmirtazapine 4.5 mg

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

Group Type: EXPERIMENTAL

Esmirtazapine

Intervention Type: DRUG

One esmirtazapine 4.5 mg tablet once a day

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One placebo tablet once a day

Interventions

Esmirtazapine

One esmirtazapine 4.5 mg tablet once a day

Intervention Type: DRUG

Placebo

One placebo tablet once a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 32351205 (View on PubMed)

Other Identifiers

21106

Identifier Type: OTHER

Identifier Source: secondary_id

2007-005236-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05701

Identifier Type: -

Identifier Source: org_study_id