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

Phase 2

Completed

• Conditions: Primary Insomnia
• Interventions: Drug: APD125; Drug: Placebo

• Registration Number: NCT00664664
• Lead Sponsor: Arena Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2020-12
• Disposition First Submitted: 2020-12-16
• Disposition First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Disposition First Posted: 2020-12-24
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 744

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	APD125	APD125 40 mg
3	Placebo	Matching Placebo
1	APD125	APD125 20 mg

Primary Outcome Measures

Name	Time	Method
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)	During and after 2 weeks of study drug

Secondary Outcome Measures

Name	Time	Method
Change from baseline in subjective total sleep time (sTST)	During and after 2 weeks on study drug
Change from baseline in subjective wake time after sleep onset (sWASO)	During and after 2 weeks on study drug
Change in subjective latency to sleep onset (sSLO)	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.	During and after 2 weeks on study drug

Trial Locations

Locations (1)

Arena Pharmaceuticals, Inc; 🇺🇸 San Diego, California, United States