Safety and Efficacy Study of APD125 in Patient With Insomnia

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00452179
First received: March 23, 2007
Last updated: September 6, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: APD125
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • Conventional PSG parameters

Secondary Outcome Measures:
  • Patient reported subjective sleep parameters

Enrollment: 173
Study Start Date: February 2007
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452179

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00452179     History of Changes
Other Study ID Numbers: APD125-004
Study First Received: March 23, 2007
Last Updated: September 6, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014