Status:
COMPLETED
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
Lead Sponsor:
Evotec Neurosciences GmbH
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00401284
Start Date
November 1 2006
End Date
July 1 2007
Last Update
January 7 2008
Active Locations (22)
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1
PsyPharma Clinical Research Inc.
Phoenix, Arizona, United States, 85050
2
PsyPharma Clinical Research, Inc.
Tucson, Arizona, United States, 85712
3
Pacific Sleep Medicine Services Inc
Los Angeles, California, United States, 90048
4
Pacific Sleep Medicine Services
San Diego, California, United States, 92121