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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401284
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : January 7, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: EVT 201 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness
Study Start Date : November 2006
Actual Study Completion Date : July 2007

Primary Outcome Measures :
  1. Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7

Secondary Outcome Measures :
  1. Mean Multiple Sleep Latency Test at Day 8
  2. Mean Psychomotor Vigilance Task at Day 8
  3. Mean Karolinska Sleepiness Scale at Day 8
  4. Mean Rey Auditory Verbal Learning Test at Day 8
  5. Mean Profile of Mood State at Day 8
  6. Polysomnography derived variables averaged over nights 1, 6 and 7
  7. Patient reported evaluations of sleep quality and quantity over nights 1 to 7
  8. Benzodiazepine withdrawal questionnaire at baseline and follow-up
  9. Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401284

United States, Arizona
PsyPharma Clinical Research Inc.
Phoenix, Arizona, United States, 85050
PsyPharma Clinical Research, Inc.
Tucson, Arizona, United States, 85712
United States, California
Pacific Sleep Medicine Services Inc
Los Angeles, California, United States, 90048
Pacific Sleep Medicine Services
San Diego, California, United States, 92121
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
OmniTrials, 11181 Health Park Blvd, Suite 3040
Naples, Florida, United States, 34110
Broward Research Group
Pembroke Pines, Florida, United States, 33026
Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S
St Petersburg, Florida, United States, 33707
United States, Georgia
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, United States, 30342
Sleep Disorders Center of Georgia - Gainesville
Gainesville, Georgia, United States, 30501
United States, Kansas
Vince and Assocaites Clinical Research
Overland Park, Kansas, United States, 66212
United States, Kentucky
Community Research
Crestview Hills, Kentucky, United States, 41017
United States, Mississippi
Center for Sleep Medicine, 101 Courtney Circle
Hattiesburg, Mississippi, United States, 39402
United States, Missouri
Sleep Medicine and Research Center, 232 S. Woods Mill Road
Chesterfield (St Louis), Missouri, United States, 63017
United States, New York
Clinilabs, Inc., 423 West 55th Street, 4th Floor
New York, New York, United States, 10019
United States, North Carolina
Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
Durham, North Carolina, United States, 27710
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45227
Tri-State Sleep Disorders Center, 1275 East Kemper Road
Cincinnati, Ohio, United States, 45246
United States, Rhode Island
Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
Providence, Rhode Island, United States, 02906
United States, South Carolina
Sleep Disorders Center, 1333 Taylor Street, Suite 5A
Columbia, South Carolina, United States, 29201
United States, Texas
Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
Dallas, Texas, United States, 75231
Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344
Houston, Texas, United States, 77030
Sponsors and Collaborators
Evotec Neurosciences GmbH
Principal Investigator: James K Walsh, PhD St Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI Identifier: NCT00401284     History of Changes
Other Study ID Numbers: 2005
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders