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

December 16, 2020 updated by: Arena Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

744

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Arena Pharmaceuticals, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
APD125 20 mg
Drug: APD125
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
Drug: APD125
soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
Experimental: 2
APD125 40 mg
Drug: APD125
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
Time Frame: During and after 2 weeks of study drug
During and after 2 weeks of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in subjective total sleep time (sTST)
Time Frame: During and after 2 weeks on study drug
During and after 2 weeks on study drug
Change from baseline in subjective wake time after sleep onset (sWASO)
Time Frame: During and after 2 weeks on study drug
During and after 2 weeks on study drug
Change in subjective latency to sleep onset (sSLO)
Time Frame: During and after 2 weeks on study drug
During and after 2 weeks on study drug
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
During and after 2 weeks on study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arena Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD125-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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