Safety and Efficacy Study of APD125 in Patient With Insomnia

A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00452179

Enrollment

173

Registered

2007-03-27

Start date

2007-02-28

Completion date

2007-06-30

Last updated

2007-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Sleep maintenance, Insomnia, Sleep Consolidation, Sleep, Insomnia, primarily sleep maintenance

Brief summary

The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

Interventions

DRUGAPD125

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Inclusion criteria

* Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG * PSQI \>/= to 5 * Qualifying screening PSG parameters * 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 * Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) \> 10 as determined by screening PSG * 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

Design outcomes

Primary

Measure	Time frame
Conventional PSG parameters	—

Secondary

Measure	Time frame
Patient reported subjective sleep parameters	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026