Efficacy Study of EVT 201 to Treat Insomnia
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients
1 other identifier
interventional
66
1 country
5
Brief Summary
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2006
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 30, 2008
January 1, 2008
September 22, 2006
January 29, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
Total Sleep Time
Wake after sleep onset
Secondary Outcomes (8)
Latency to persistent sleep
Number of awakenings
Total wake time
Minutes of stages 1-4 and REM sleep
REM latency
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- must have a diagnosis of primary insomnia
- over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
- must be willing and able to complete a sleep diary and questionnaires
You may not qualify if:
- must not have a clinically significant or unstable medical condition that may interfere with sleep
- must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
- must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
- must not intentionally nap 3 (or more) times per week
- must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
St Petersburg Sleep Disorders Center
St. Petersburg, Florida, 33707, United States
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, 30342, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
St. Luke's Hospital
Chesterfield (St Louis), Missouri, 63017, United States
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45246, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James K Walsh, PhD
St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 25, 2006
Study Start
September 1, 2006
Study Completion
April 1, 2007
Last Updated
January 30, 2008
Record last verified: 2008-01