NCT00308503

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
608

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

1.5 years

First QC Date

March 28, 2006

Last Update Submit

November 29, 2010

Conditions

Sleep Initiation and Maintenance DisordersInsomnia

Keywords

Primary InsomniaSleep Maintenance InsomniaAwakening

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)

    week 6

Secondary Outcomes (2)

  • Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)

    week 6

  • Change from baseline in patient reported wake after sleep onset (pr-WASO)

    week 6

Study Arms (2)

1

EXPERIMENTAL

5 mg/day

Drug: eplivanserin (SR46349)

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

eplivanserin (SR46349)DRUG

oral administration

1
placeboDRUG

oral administration

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanofi-Aventis

Bridgewater, New York, 08807, United States

Location

Sanofi-Aventis

Macquarie Park, New South Wales, Australia

Location

Sanofi-Aventis

Laval, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

SR 46349B

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations

CA(1)AU(1)US(1)