Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia - Full Text View

Sponsored by:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00664664

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 II

Drug Information available for: Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental APD125 20 mg	Drug: APD125 soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
2: Experimental APD125 40 mg	Drug: APD125 soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
3: Placebo Comparator 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

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

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

Keywords provided by Arena Pharmaceuticals:

insomnia
sleep maintenance insomnia
sleep quality
non-restorative sleep
multiple awakenings

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009