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.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,155

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2005

Typical duration for phase_3

Geographic Reach

13 countries

13 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

November 1, 2005

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed

Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

2 years

First QC Date

November 14, 2005

Last Update Submit

November 29, 2010

Conditions

Sleep Initiation and Maintenance Disorders Insomnia

Keywords

Primary InsomniaSleeplessnessEarly AwakeningChronic Insomnia

Outcome Measures

Primary Outcomes (1)

Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
at week 12

Secondary Outcomes (2)

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

Study Arms (2)

1

EXPERIMENTAL

5 mg/day

Drug: eplivanserin (SR46349)

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

eplivanserin (SR46349)DRUG

oral administration

placeboDRUG

oral administration

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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
+9 more criteria

Contact the study team to confirm eligibility.