Efficacy an Safety of Volinanserin on Sleep Maintenance I... | NCT00464061

Studies
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

NCT00464061

Sponsor

Sanofi

Status

Terminated

Last Update Posted

May 26, 2016Estimated

Enrollment

1,847Actual

Phase

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Volinanserin
Placebo

Countries

United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
Colombia
Czechia
Germany
Hong Kong
India
Italy
Malaysia
Mexico
Russia
Singapore
South Africa
Spain
Turkey (Türkiye)
United Kingdom

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

ID	Type	Description	Link
EudraCT : 2006-004942-18

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Apr 19, 2007

First Submission Date that Met QC Criteria

Apr 19, 2007

First Posted Date

Apr 20, 2007Estimated

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

Apr 26, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 26, 2016

Certification/Extension First Posted Date

May 26, 2016Estimated

Last Update Submitted Date

Apr 26, 2016

Last Update Posted Date

May 26, 2016Estimated

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

1,847Actual

Label	Type	Description	Intervention Names
Volinanserin	Experimental		Drug: Volinanserin
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Volinanserin	Drug	oral administration	Volinanserin	M100907

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)		at 3 months
Efficacy (sub-study): change from baseline for glycemic measure HbA1c		at 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: change from baseline of the pr-WASO		at 6 and 12 months
Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire		at 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
Disturbances of sleep maintenance criteria based on participant's information related to sleep pattern during the preceding month

Sub-study :

Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)

Exclusion Criteria:

Females who are lactating or who are pregnant
Night shift workers, and individuals who nap 3 or more times per week over the preceding month
Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
Participation in another trial having received study medication within 1 month before the screening visit
Body Mass Index ≥ 33
Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
Use of any substance with psychotropic effects or properties know to affect sleep/wake
History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)

The above information is not intended to contain all considerations relevant to a participant'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

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

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D020447	Parasomnias