Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia C... | NCT00805350

Studies
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties

NCT00805350

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 7, 2016Estimated

Enrollment

637Actual

Phase

Phase 3

Conditions

Primary Insomnia

Interventions

Eplivanserin
Placebo

Countries

United States
Austria
Canada
France
Germany
Hungary
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-003791-22	EudraCT Number

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Dec 4, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 5, 2016

Certification/Extension First Submitted that Passed QC Review

Feb 5, 2016

Certification/Extension First Posted Date

Mar 7, 2016Estimated

Last Update Submitted Date

Feb 5, 2016

Last Update Posted Date

Mar 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks

Duration of observation: 9 weeks

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

637Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eplivanserin	Experimental	Eplivanserin 5 mg/day	Drug: Eplivanserin
Placebo	Placebo Comparator	Placebo of Eplivanserin 5 mg/day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eplivanserin	Drug	one 5 mg tablet once a day	Eplivanserin	SR46349

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C076033	SR 46349B

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided