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

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
APD125
APD125
Placebo
Sponsored by
Arena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring insomnia, sleep maintenance insomnia, sleep quality, non-restorative sleep, multiple awakenings

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arena Pharmaceuticals, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

APD125 20 mg

APD125 40 mg

Matching Placebo

Outcomes

Primary Outcome Measures

Change from baseline in subjective number of awakenings after sleep onset (sNAASO)

Secondary Outcome Measures

Change from baseline in subjective total sleep time (sTST)
Change from baseline in subjective wake time after sleep onset (sWASO)
Change in subjective latency to sleep onset (sSLO)
Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values.

Full Information

First Posted
April 21, 2008
Last Updated
December 16, 2020
Sponsor
Arena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00664664
Brief Title
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
insomnia, sleep maintenance insomnia, sleep quality, non-restorative sleep, multiple awakenings

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
744 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
APD125 20 mg
Arm Title
2
Arm Type
Experimental
Arm Description
APD125 40 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
APD125
Intervention Description
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
Intervention Type
Drug
Intervention Name(s)
APD125
Intervention Description
soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
soft gelatin capsule, daily dosing for up to 3 weeks
Primary Outcome Measure Information:
Title
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
Time Frame
During and after 2 weeks of study drug
Secondary Outcome Measure Information:
Title
Change from baseline in subjective total sleep time (sTST)
Time Frame
During and after 2 weeks on study drug
Title
Change from baseline in subjective wake time after sleep onset (sWASO)
Time Frame
During and after 2 weeks on study drug
Title
Change in subjective latency to sleep onset (sSLO)
Time Frame
During and after 2 weeks on study drug
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arena Pharmaceuticals, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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