VSF-173 Study in Healthy Adult Volunteers for Treatment o... | NCT00467441

Studies
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness

NCT00467441

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Nov 2, 2007Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Excessive Somnolence

Interventions

VSF-173

Countries

France

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

Status Module

Record Verification Date

Oct 2007

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 26, 2007

First Submission Date that Met QC Criteria

Apr 26, 2007

First Posted Date

Apr 30, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2007

Last Update Posted Date

Nov 2, 2007Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
VSF-173	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)

Secondary Outcomes

Measure	Description	Time Frame
Mood
Psychomotor performance
Safety and tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects with no medical, psychiatric, or current sleep disorders
Subject must sign a written consent form

Exclusion Criteria:

Evidence of excessive daytime sleepiness
History of sleep disorders
Psychiatric or neurological disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided