Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
- Conditions
- Sleep Initiation and Maintenance Disorders
- Registration Number
- NCT00401284
- Lead Sponsor
- Evotec Neurosciences GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
- Secondary Outcome Measures
Name Time Method 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 Polysomnography derived variables averaged over nights 1, 6 and 7 Patient reported evaluations of sleep quality and quantity over nights 1 to 7 Benzodiazepine withdrawal questionnaire at baseline and follow-up Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study
Trial Locations
- Locations (21)
Pacific Sleep Medicine Services Inc
🇺🇸Los Angeles, California, United States
Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
🇺🇸Dallas, Texas, United States
Broward Research Group
🇺🇸Pembroke Pines, Florida, United States
OmniTrials, 11181 Health Park Blvd, Suite 3040
🇺🇸Naples, Florida, 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
Vince and Assocaites Clinical Research
🇺🇸Overland Park, Kansas, United States
PsyPharma Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Sleep Disorders Center of Georgia - Gainesville
🇺🇸Gainesville, Georgia, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
PsyPharma Clinical Research Inc.
🇺🇸Phoenix, Arizona, United States
Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
🇺🇸Durham, North Carolina, United States
Pacific Sleep Medicine Services
🇺🇸San Diego, California, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Tri-State Sleep Disorders Center, 1275 East Kemper Road
🇺🇸Cincinnati, Ohio, United States
Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344
🇺🇸Houston, Texas, 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, 1333 Taylor Street, Suite 5A
🇺🇸Columbia, South Carolina, United States
Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
🇺🇸Providence, Rhode Island, United States
Center for Sleep Medicine, 101 Courtney Circle
🇺🇸Hattiesburg, Mississippi, United States