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

Primary Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664664
• Other study ID #: APD125-007
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2020
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• APD125
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
• APD125
soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
• Placebo
soft gelatin capsule, daily dosing for up to 3 weeks

Locations

Country	Name	City	State
United States	Arena Pharmaceuticals, Inc	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Arena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in subjective number of awakenings after sleep onset (sNAASO)		During and after 2 weeks of study drug
Secondary	Change from baseline in subjective total sleep time (sTST)		During and after 2 weeks on study drug
Secondary	Change from baseline in subjective wake time after sleep onset (sWASO)		During and after 2 weeks on study drug
Secondary	Change in subjective latency to sleep onset (sSLO)		During and after 2 weeks on study drug
Secondary	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