NCT00664664

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

A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 744 (actual)
• Sponsor: Arena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	APD125	soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
DRUG	APD125	soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
DRUG	Placebo	soft gelatin capsule, daily dosing for up to 3 weeks

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2008-04-23
• Last updated: 2020-12-24

Locations

1 site across 1 country: United States