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

NCT00664664 | Completed Phase 2

• 1 other identifier: APD125-007
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  During and after 2 weeks of study drug

Secondary Outcomes (4)

• Change from baseline in subjective total sleep time (sTST)

  During and after 2 weeks on study drug

• Change from baseline in subjective wake time after sleep onset (sWASO)

  During and after 2 weeks on study drug

• Change in subjective latency to sleep onset (sSLO)

  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.

  During and after 2 weeks on study drug

Study Arms (3)

1

EXPERIMENTAL

APD125 20 mg

Drug: APD125

2

EXPERIMENTAL

APD125 40 mg

Drug: APD125

3

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

APD125 DRUG

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

1

Placebo DRUG

soft gelatin capsule, daily dosing for up to 3 weeks

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arena Pharmaceuticals: lead

Study Sites (1)

Arena Pharmaceuticals, Inc

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Arena CT.gov Administrator

  Arena Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

US (1)