NCT00683436

Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs

A Multi-Center, Randomized, Blinded, Active and Placebo-Controlled, Crossover Study of the Efficacy and Safety of Two Doses of Adipiplon Bilayer Tablets in Primary Insomniacs

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Neurogen Corporation · Industry
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.

Detailed description

Prospective patients will spend 2 nights in the sleep lab for baseline PSG assessments. Those who meet the protocol inclusion/exclusion criteria will return for four treatment periods with two consecutive nights in each. Study medication will be administered in the sleep laboratory 30 minutes before the patient's usual bedtime.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	Adipiplon	bilayer tablets 6 mg
DRUG	Placebo	Placebo
DRUG	Ambien CR	Ambien CR 12.5 mg
DRUG	Adipiplon	bilayer tablets 9 mg

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2008-05-23
• Last updated: 2008-07-22

Locations

9 sites across 1 country: United States