Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year | Completed
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year
EPLILONG
Trial Source

Health Conditions
  • Sleep Initiation and Maintenance Disorders
  • Insomnia
Completed
Recruitment Status
NCT00253903
Primary Trial ID Number
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.
Primary Outcome Measures
  • Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire); at week 12
Secondary Outcome Measures
  • Change from baseline of the mean of the FOSQ items 1 and 2 (concentration/memory); at week 12; Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work); at week 12
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United States; Argentina; Australia; Austria; Canada; Chile; Czech Republic; Finland; France; Germany; Mexico; Netherlands; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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)
Participant Exclusion 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)
Interventions
Drug; eplivanserin (SR46349); oral administration; [1]; Drug; placebo; oral administration; [2]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
EPLILONG
Scientific 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
Secondary Trial Identifying Number
EucraCT: 2005-003082-16
Website
Sorry, this information is not available
Study Funded By
Sanofi
Funder Type
Sorry, this information is not available
Study Sponsored By
Sanofi
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

14 Nov 2005

Last Updated

29 Nov 2010

Date Record Refreshed on UKCTG

31 Jul 2015