Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness
1 other identifier
interventional
135
1 country
22
Brief Summary
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 17, 2006
CompletedFirst Posted
Study publicly available on registry
November 20, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 7, 2008
January 1, 2008
November 17, 2006
January 2, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
Secondary Outcomes (9)
Mean Multiple Sleep Latency Test at Day 8
Mean Psychomotor Vigilance Task at Day 8
Mean Karolinska Sleepiness Scale at Day 8
Mean Rey Auditory Verbal Learning Test at Day 8
Mean Profile of Mood State at Day 8
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of primary insomnia according to DSM-IV
- Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- A history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night
- Able to attend the Sleep Center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period
- Willing and able to complete a sleep diary and questionnaires
You may not qualify if:
- Clinically significant or unstable medical condition that may interfere with sleep
- Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder
- History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening
- History of substance abuse
- Disorders that interfere with drug pharmacokinetics
- History of cancer, except basal cell carcinoma
- Use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of Parkinson's disease such as dopamine agonists and L-dopa (e.g., Sinemet, Madopar or Requip)
- Use of hypnotics within the 2 weeks preceding the Screening Period or within five half-lives of the medication, whichever is longer
- Consuming ≥ 350 mg per day of xanthine-containing food or beverages
- Smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours)
- Body mass index \> 34 kg/m2;
- Performing night work or rotating shift work during the past month
- Traveling across \> 3 time zones in the past 2 weeks
- Participation in another trial of an investigational product or device within the previous 30 days
- Known allergy or sensitivity to benzodiazepines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
PsyPharma Clinical Research Inc.
Phoenix, Arizona, 85050, United States
PsyPharma Clinical Research, Inc.
Tucson, Arizona, 85712, United States
Pacific Sleep Medicine Services Inc
Los Angeles, California, 90048, United States
Pacific Sleep Medicine Services
San Diego, California, 92121, United States
Miami Research Associates
Miami, Florida, 33143, United States
OmniTrials, 11181 Health Park Blvd, Suite 3040
Naples, Florida, 34110, United States
Broward Research Group
Pembroke Pines, Florida, 33026, United States
Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S
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
Sleep Disorders Center of Georgia - Gainesville
Gainesville, Georgia, 30501, United States
Vince and Assocaites Clinical Research
Overland Park, Kansas, 66212, United States
Community Research
Crestview Hills, Kentucky, 41017, United States
Center for Sleep Medicine, 101 Courtney Circle
Hattiesburg, Mississippi, 39402, United States
Sleep Medicine and Research Center, 232 S. Woods Mill Road
Chesterfield (St Louis), Missouri, 63017, United States
Clinilabs, Inc., 423 West 55th Street, 4th Floor
New York, New York, 10019, United States
Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
Durham, North Carolina, 27710, United States
Community Research
Cincinnati, Ohio, 45227, United States
Tri-State Sleep Disorders Center, 1275 East Kemper Road
Cincinnati, Ohio, 45246, United States
Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
Providence, Rhode Island, 02906, United States
Sleep Disorders Center, 1333 Taylor Street, Suite 5A
Columbia, South Carolina, 29201, United States
Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
Dallas, Texas, 75231, United States
Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344
Houston, Texas, 77030, 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
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2006
First Posted
November 20, 2006
Study Start
November 1, 2006
Study Completion
July 1, 2007
Last Updated
January 7, 2008
Record last verified: 2008-01