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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Sleep Disorders

Dyssomnias

Sleep Initiation and Maintenance Disorders

Mental Disorders

Sleep Disorder, Intrinsic

Treatments

Drug: Esmirtazapine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00631657

21106 (Other Identifier)

P05701

2007-005236-92 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

460 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.