Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness

Completed · Phase 2

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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.

Key facts

Study ID

NCT00401284

Run by

Evotec Neurosciences GmbH

People needed

135

Starts

2006-11-01

Expected to finish

2007-07-01

Last updated by the study team

2008-01-07

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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