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

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ClinicalTrials.gov Identifier: NCT00664664
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 30, 2008
Sponsor:
Information provided by:
Arena Pharmaceuticals

Brief Summary:

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 or disease Intervention/treatment Phase
Primary Insomnia Drug: APD125 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 675 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from baseline in subjective number of awakenings after sleep onset (sNAASO) [ Time Frame: During and after 2 weeks of study drug ]

Secondary Outcome Measures :
  1. Change from baseline in subjective total sleep time (sTST) [ Time Frame: During and after 2 weeks on study drug ]
  2. Change from baseline in subjective wake time after sleep onset (sWASO) [ Time Frame: During and after 2 weeks on study drug ]
  3. Change in subjective latency to sleep onset (sSLO) [ Time Frame: During and after 2 weeks on study drug ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00664664


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

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
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: December 30, 2008
Last Verified: December 2008

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
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders