Brief Summary

Primary objective: \- To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW). Secondary objectives:

To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS).
To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo.
To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment.
To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire.
To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo.
To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo.
To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey.
To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

Trial Health

On Track

Trial Health Score

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

Enrollment

637

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2008

Shorter than P25 for phase_3

Geographic Reach

7 countries

7 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

6 months study duration

Study Start

First participant enrolled

December 1, 2008

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed

Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

December 4, 2008

Last Update Submit

February 5, 2016

Conditions

Primary Insomnia

Keywords

InsomniaSleep MaintenancePolysomnography

Outcome Measures

Primary Outcomes (2)

Change from baseline of mean PSG-WASO on N41/N42
6 weeks
Change from baseline of mean PSG-NAW on N41/N42
6 weeks

Secondary Outcomes (6)

Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS
6 weeks
Patient-reported sleep parameters
6 weeks
Patient Global impression (PGI)
6 weeks
sleep architecture: percentage of time spent in each sleep stage (1, 2, 3-4/SWS, REM), shift to stage 1, shift to wake, stage 1 + WASO, [stages 3&4]/[stage 1 + WASO]).
6 weeks
Sleep Impact Scale (SIS)
6 weeks
+1 more secondary outcomes

Study Arms (2)

Eplivanserin

EXPERIMENTAL

Eplivanserin 5 mg/day

Drug: Eplivanserin

Placebo

PLACEBO COMPARATOR

Placebo of Eplivanserin 5 mg/day

Drug: Placebo

Interventions

EplivanserinDRUG

one 5 mg tablet once a day

Also known as: SR46349

Eplivanserin

PlaceboDRUG

Placebo of Eplivanserin one tablet once a day

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria

You may not qualify if:

Inpatients.
Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening night with PSG-WASO \< 30 mn.
Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours.
Mean screening PSG-LPS for screening night 1+ screening night 2 \> 30 mn.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.