Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
NCT ID: NCT00401284
Last Updated: 2008-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2006-11-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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EVT 201
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Evotec Neurosciences GmbH
INDUSTRY
Principal Investigators
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James K Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
St Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
Locations
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PsyPharma Clinical Research Inc.
Phoenix, Arizona, United States
PsyPharma Clinical Research, Inc.
Tucson, Arizona, United States
Pacific Sleep Medicine Services Inc
Los Angeles, California, United States
Pacific Sleep Medicine Services
San Diego, California, United States
Miami Research Associates
Miami, Florida, United States
OmniTrials, 11181 Health Park Blvd, Suite 3040
Naples, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S
St. Petersburg, Florida, United States
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, United States
Sleep Disorders Center of Georgia - Gainesville
Gainesville, Georgia, United States
Vince and Assocaites Clinical Research
Overland Park, Kansas, United States
Community Research
Crestview Hills, Kentucky, United States
Center for Sleep Medicine, 101 Courtney Circle
Hattiesburg, Mississippi, United States
Sleep Medicine and Research Center, 232 S. Woods Mill Road
Chesterfield (St Louis), Missouri, United States
Clinilabs, Inc., 423 West 55th Street, 4th Floor
New York, New York, United States
Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
Durham, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Tri-State Sleep Disorders Center, 1275 East Kemper Road
Cincinnati, Ohio, United States
Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
Providence, Rhode Island, United States
Sleep Disorders Center, 1333 Taylor Street, Suite 5A
Columbia, South Carolina, United States
Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
Dallas, Texas, United States
Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344
Houston, Texas, United States
Countries
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Other Identifiers
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2005
Identifier Type: -
Identifier Source: org_study_id
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