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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Insomnia

Treatments

Drug: placebo

Drug: eplivanserin (SR46349)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00308503

EFC6220

Details and patient eligibility

About

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.

Enrollment

608 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)