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

Arena Pharmaceuticals744 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

744

Conditions

Primary Insomnia

Interventions

APD125DRUG

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

APD125DRUG

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

PlaceboDRUG

soft gelatin capsule, daily dosing for up to 3 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Arena Pharmaceuticals, Inc

San Diego, California, United States

Outcomes

Primary Outcomes

Change from baseline in subjective number of awakenings after sleep onset (sNAASO)

Time frame: During and after 2 weeks of study drug

Secondary Outcomes

Change from baseline in subjective total sleep time (sTST)

Time frame: During and after 2 weeks on study drug

Change from baseline in subjective wake time after sleep onset (sWASO)

Time frame: During and after 2 weeks on study drug

Change in subjective latency to sleep onset (sSLO)

Time frame: During and after 2 weeks on study drug

Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values.

Time frame: During and after 2 weeks on study drug

Data from ClinicalTrials.gov

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