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OpenTrials
Completed

NCT Number: NCT00452179

Safety and Efficacy Study of APD125 in Patient With Insomnia

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Diego, California, 92121, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APD125

Drug

Primary outcomes

  1. Conventional PSG parameters

Secondary outcomes

  1. Patient reported subjective sleep parameters

Sponsors and collaborators

Lead sponsor

Arena Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Mar 27, 2007
Registry last updated
Sep 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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