Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

Summary

The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.

Timeline

Start

2007-10

Primary completion

2008-05

Completion

2008-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Ramelteon 1 mg QD vs Placebo QD; p = 0.646; ANCOVA; NCT00593736 ↗

registry analysis (superiority or other test); Ramelteon 4 mg QD vs Placebo QD; p = 0.084; ANCOVA; NCT00593736 ↗

registry analysis (superiority or other test); Ramelteon 8 mg QD vs Placebo QD; p = 0.929; ANCOVA; NCT00593736 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	1 mg	Oral
Subject	Ramelteon	Unknown	4 mg	Oral
Subject	Ramelteon	Unknown	8 mg	Oral

Indications