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Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year (EPLILONG)

Primary Purpose

Sleep Initiation and Maintenance Disorders, Insomnia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
eplivanserin (SR46349)
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Primary Insomnia, Sleeplessness, Early Awakening, Chronic Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Out patients Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria Based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks. Based on patient's information, the 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 daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit. Exclusion Criteria: Females who are lactating or pregnant Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception Patients presenting with acute or chronic pain resulting in insomnia Patients with history of epilepsy or seizures Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety BMI >32 Acute or chronic pain resulting in insomnia Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia Clinically significant and abnormal EKG (QTc interval >500 msec) Positive for hepatitis B or C Serious head injury or stroke within 1 year Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives Participation in another trial within two month before the screening visit Use of any substance with psychotropic effects or properties known to affect sleep/wake Unable to complete the study questionnaires Night shift workers, and individuals who nap 3 or more times per week over the preceding month History of: Primary hypersomnia Narcolepsy Breathing-related sleep disorder (such as sleep apnea) Circadian rhythm sleep disorder Parasomnia (somnambulism) Dyssomnia (such as periodic leg movements)

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

5 mg/day

Outcomes

Primary Outcome Measures

Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)

Secondary Outcome Measures

Change from baseline of the mean of the FOSQ items 1 and 2 (concentration/memory)
Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)

Full Information

First Posted
November 14, 2005
Last Updated
November 29, 2010
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00253903
Brief Title
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year
Acronym
EPLILONG
Official Title
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Detailed Description
The study is being conducted worldwide. It consists of 4 segments: Segment A: 7-day run-in (screening) Segment B: 12-week double blind treatment Segment C: 40-week open treatment extension Segment D: 2-week run-out period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Insomnia
Keywords
Primary Insomnia, Sleeplessness, Early Awakening, Chronic Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
5 mg/day
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
eplivanserin (SR46349)
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
Change from baseline of the mean of the FOSQ items 1 and 2 (concentration/memory)
Time Frame
at week 12
Title
Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)
Time Frame
at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Out patients Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria Based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks. Based on patient's information, the 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 daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit. Exclusion Criteria: Females who are lactating or pregnant Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception Patients presenting with acute or chronic pain resulting in insomnia Patients with history of epilepsy or seizures Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety BMI >32 Acute or chronic pain resulting in insomnia Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia Clinically significant and abnormal EKG (QTc interval >500 msec) Positive for hepatitis B or C Serious head injury or stroke within 1 year Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives Participation in another trial within two month before the screening visit Use of any substance with psychotropic effects or properties known to affect sleep/wake Unable to complete the study questionnaires Night shift workers, and individuals who nap 3 or more times per week over the preceding month History of: Primary hypersomnia Narcolepsy Breathing-related sleep disorder (such as sleep apnea) Circadian rhythm sleep disorder Parasomnia (somnambulism) Dyssomnia (such as periodic leg movements)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Vienna
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

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