Safety and Efficacy Study of APD125 in Patient With Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00452179
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : September 10, 2007
Information provided by:
Arena Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Insomnia Drug: APD125 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2007
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. Conventional PSG parameters

Secondary Outcome Measures :
  1. Patient reported subjective sleep parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00452179

United States, California
San Diego, California, United States, 92121
Sponsors and Collaborators
Arena Pharmaceuticals
Study Director: Warren A Prosser Arena Pharmaceuticals

Additional Information: Identifier: NCT00452179     History of Changes
Other Study ID Numbers: APD125-004
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: September 10, 2007
Last Verified: September 2007

Keywords provided by Arena Pharmaceuticals:
Sleep maintenance
Sleep Consolidation
Insomnia, primarily sleep maintenance

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders