Safety and Efficacy Study of APD125 in Patient With Insomnia

Arena Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Insomnia

Treatments

Drug: APD125

Study type

Interventional

Funder types

Industry

Identifiers

APD125-004

Details and patient eligibility

About

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

Enrollment

173 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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