A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

Eisai

Status and phase: Completed; Phase 3; Phase 2

Conditions: Primary Insomnia

Treatments: Drug: Zolpidem Tartrate 10 mg; Drug: Eszopiclone 3 mg; Drug: Eszopiclone 1 mg; Drug: Eszopiclone 2 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770510

190-126

Details and patient eligibility

About

The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

Full description

This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.

Enrollment: 192 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

2. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

   • Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
   • Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week

3. Participants who meet both of the following based on polysomnogram (PSG) in observation period:

   • Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
   • Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion criteria

1. Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
3. Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
4. Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
5. Participants with organic mental disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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192 participants in 5 patient groups, including a placebo group

Eszopiclone 1 mg

Experimental group

Treatment:

Drug: Eszopiclone 1 mg

Eszopiclone 2 mg

Experimental group

Treatment:

Drug: Eszopiclone 2 mg

Eszopiclone 3 mg

Experimental group

Treatment:

Drug: Eszopiclone 3 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Zolpidem Tartrate 10 mg

Active Comparator group

Treatment:

Drug: Zolpidem Tartrate 10 mg