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

NCT ID: NCT00664664

Last Updated: 2020-12-24

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

744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Primary Insomnia

Keywords

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insomnia sleep maintenance insomnia sleep quality non-restorative sleep multiple awakenings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

APD125 20 mg

Group Type EXPERIMENTAL

APD125

Intervention Type DRUG

soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks

2

APD125 40 mg

Group Type EXPERIMENTAL

APD125

Intervention Type DRUG

soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks

3

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

soft gelatin capsule, daily dosing for up to 3 weeks

Interventions

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APD125

soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks

Intervention Type DRUG

APD125

soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks

Intervention Type DRUG

Placebo

soft gelatin capsule, daily dosing for up to 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arena Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arena CT.gov Administrator

Role: STUDY_DIRECTOR

Arena Pharmaceuticals

Locations

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Arena Pharmaceuticals, Inc

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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APD125-007

Identifier Type: -

Identifier Source: org_study_id