Safety and Efficacy Study of APD125 in Patient With Insomnia | NCT00452179

Studies
Safety and Efficacy Study of APD125 in Patient With Insomnia

NCT00452179

Sponsor

Arena Pharmaceuticals

Status

Completed

Last Update Posted

Sep 10, 2007Estimated

Enrollment

173Actual

Phase

Phase 2

Conditions

Insomnia

Interventions

APD125

Countries

United States

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

Sep 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

Not provided

Start Date

Feb 2007

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Mar 23, 2007

First Submission Date that Met QC Criteria

Mar 26, 2007

First Posted Date

Mar 27, 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

Sep 6, 2007

Last Update Posted Date

Sep 10, 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

173Actual

Name	Type	Description	Arm Group Labels	Other Names
APD125	Drug

Measure	Description	Time Frame
Conventional PSG parameters

Measure	Description	Time Frame
Patient reported subjective sleep parameters

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
PSQI >/= to 5
Qualifying screening PSG parameters
Generally good health

Exclusion Criteria:

History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
Any clinically significant medical condition, laboratory finding, or ECG finding
Pregnant and/or lactating females
History of substance abuse within 2 years or positive urine drug screen
Positive Hepatitis B/C results or HIV markers
Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) > 10 as determined by screening PSG
History of treatment with an investigational drug within the last month
Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (> 3 time zones) during the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Warren A Prosser	Arena Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		San Diego	California	92121	United States

Label	URL
Arena Pharmaceuticals Home Page	View source

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