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Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00664664
First received: April 21, 2008
Last updated: December 29, 2008
Last verified: December 2008
  Purpose

This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep.

Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.


Condition Intervention Phase
Primary Insomnia
Drug: APD125
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in subjective number of awakenings after sleep onset (sNAASO) [ Time Frame: During and after 2 weeks of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in subjective total sleep time (sTST) [ Time Frame: During and after 2 weeks on study drug ] [ Designated as safety issue: No ]
  • Change from baseline in subjective wake time after sleep onset (sWASO) [ Time Frame: During and after 2 weeks on study drug ] [ Designated as safety issue: No ]
  • Change in subjective latency to sleep onset (sSLO) [ Time Frame: During and after 2 weeks on study drug ] [ Designated as safety issue: No ]
  • Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values. [ Time Frame: During and after 2 weeks on study drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 675
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
APD125 20 mg
Drug: APD125
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
Experimental: 2
APD125 40 mg
Drug: APD125
soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
Placebo Comparator: 3
Matching Placebo
Drug: Placebo
soft gelatin capsule, daily dosing for up to 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ages 18 to 65 years
  • Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
  • 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
  • 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: NCT00664664

Locations
United States, California
Arena Pharmaceuticals, Inc
San Diego, California, United States, 92121
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Investigator: Emil Chuang, MD Arena Pharmaceuticals
Principal Investigator: Andrew Krystal, MD Duke University
  More Information

No publications provided

Responsible Party: c/o: Vice President and Chief Medical Officer, Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00664664     History of Changes
Other Study ID Numbers: APD125-007
Study First Received: April 21, 2008
Last Updated: December 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Arena Pharmaceuticals:
insomnia
sleep maintenance insomnia
sleep quality
non-restorative sleep
multiple awakenings

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

ClinicalTrials.gov processed this record on November 20, 2014