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

Arena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Insomnia

Treatments: Drug: APD125; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664664

APD125-007

Details and patient eligibility

About

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.

Enrollment: 744 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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744 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

APD125 20 mg

Treatment:

Drug: APD125

Drug: APD125

2

Experimental group

Description:

APD125 40 mg

Treatment:

Drug: APD125

Drug: APD125

3

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo