CompletedPhase 2

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

United States744 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: During and after 2 weeks of study drug

Trial details

NCT IDNCT00664664

SponsorArena Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-10

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