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NCT00452179 Clinical Trial

Safety and Efficacy Study of APD125 in Patient With Insomnia

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452179
Other study ID # APD125-004
Secondary ID
Status Completed
Phase Phase 2
First received March 23, 2007
Last updated September 6, 2007
Start date February 2007
Est. completion date June 2007

Study information
Verified date September 2007
Source Arena Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 173
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• APD125

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Arena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Conventional PSG parameters
Secondary Patient reported subjective sleep parameters
See also
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