Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00805350

Purpose

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.

Condition	Intervention	Phase
Primary Insomnia	Drug: Eplivanserin (SR46349) Drug: Placebo	Phase III

Drug Information available for: Eplivanserin SR 46349B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-Week, Randomized, Double-Blind, Placebo-Controlled, Polysomnography Study.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline of mean PSG-WASO on N41/N42 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline of mean PSG-NAW on N41/N42 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS; 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]). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Patient-reported sleep parameters measured on patient sleep questionnaire: pr-WASO, pr-NAW, pr-TST, QoS, RQoS. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Residual effects measured by psychometric tests DSST & RAVLT in the morning and evening following nights in sleep lab, and reported by patients on sleep questionnaires (morning sleepiness, ability to concentrate in the morning). [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Eplivanserin (SR46349) one 5 mg tablet once a day
2: Placebo Comparator	Drug: Placebo one tablet once a day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of primary insomnia based on DSM-IV-TR criteria.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805350

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office	Recruiting
Bridgewater, New Jersey, United States

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10844, EudraCT 2008-003791-22
Study First Received:	December 4, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00805350
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Insomnia
Sleep Maintenance
Polysomnography

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
SR 46349B
Dyssomnias

Sleep Disorders
Serotonin
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Cardiovascular Agents

Pharmacologic Actions
Fibrin Modulating Agents
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009