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Completed

NCT Number: NCT00664664

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

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.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arena Pharmaceuticals, Inc

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APD125

Drug

soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks

Placebo

Drug

soft gelatin capsule, daily dosing for up to 3 weeks

Primary outcomes

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

    Time frame: During and after 2 weeks of study drug

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Arena Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 23, 2008
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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