Safety and Efficacy Study of APD125 in Patient With Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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APD125

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Warren A Prosser

Role: STUDY_DIRECTOR

Arena Pharmaceuticals

Locations

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San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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APD125-004

Identifier Type: -

Identifier Source: org_study_id