Subjective Study to Assess the Efficacy of APD125 in Pati... | NCT00664664

Studies
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia

NCT00664664

Sponsor

Arena Pharmaceuticals

Status

Completed

Last Update Posted

Dec 24, 2020Actual

Enrollment

744Actual

Phase

Phase 2

Conditions

Primary Insomnia

Interventions

APD125
APD125
Placebo

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

Dec 2020

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

Apr 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Apr 21, 2008

First Submission Date that Met QC Criteria

Apr 22, 2008

First Posted Date

Apr 23, 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

Dec 16, 2020

Certification/Extension First Submitted that Passed QC Review

Dec 16, 2020

Certification/Extension First Posted Date

Dec 24, 2020Actual

Last Update Submitted Date

Dec 16, 2020

Last Update Posted Date

Dec 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.

Detailed Description

Not provided

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

744Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	APD125 20 mg	Drug: APD125
2	Experimental	APD125 40 mg	Drug: APD125
3	Placebo Comparator	Matching Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
APD125	Drug	soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)		During and after 2 weeks of study drug

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in subjective total sleep time (sTST)		During and after 2 weeks on study drug
Change from baseline in subjective wake time after sleep onset (sWASO)		During and after 2 weeks on study drug

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women, ages 18 to 65 years
Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
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
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

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arena CT.gov Administrator	Arena Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arena Pharmaceuticals, Inc		San Diego	California	92121	United States

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