Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia

NCT ID: NCT00308503

Last Updated: 2010-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-08-31

Brief Summary

The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.

Conditions

Sleep Initiation and Maintenance Disorders; Insomnia

Keywords

Primary Insomnia; Sleep Maintenance Insomnia; Awakening

Study Design

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

Study Groups

1

5 mg/day

Group Type: EXPERIMENTAL

eplivanserin (SR46349)

Intervention Type: DRUG

oral administration

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

oral administration

Interventions

eplivanserin (SR46349)

oral administration

Intervention Type: DRUG

placebo

oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month preceding the study visit.
• Disturbance of sleep maintenance:

• Based on patient' s information:

• Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,
• Patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month,
• Patient must report impact on daytime functioning associated with sleep maintenance insomnia

Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the sleep laboratory during the two screening nights.

Exclusion Criteria

• Females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception
• Patients presenting with acute or chronic pain resulting in insomnia
• Patients with current psychiatric disturbances
• Body mass index > 32
• Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety
• Clinically significant and abnormal electrocardiogram (ECG) (including QTc B > 500ms),
• A positive test for hepatitis B (hepatitis B surface [HBs] antigens) or C (hepatitis C virus [HCV] antibodies)
• Positive qualitative urine drug screen at screening
• Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day
• Use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening
• Night shift workers, and individuals who nap 3 or more times per week over the preceding month
• Based on medical history and/or NPSG:

• primary hypersomnia
• narcolepsy
• breathing-related sleep disorder (apnea-hypopnea index > 10/hour of sleep)
• circadian rhythm sleep disorder
• parasomnia (e.g. somnambulism)

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

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New York, United States

Sanofi-Aventis

Macquarie Park, New South Wales, Australia

Sanofi-Aventis

Laval, , Canada

Countries

Argentina; United States; Australia; Canada

Other Identifiers

EFC6220

Identifier Type: -

Identifier Source: org_study_id