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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness

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.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: EVT 201

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • PsyPharma Clinical Research Inc.
    • Tucson, Arizona, United States, 85712
      • PsyPharma Clinical Research, Inc.
  • California
    • Los Angeles, California, United States, 90048
      • Pacific Sleep Medicine Services Inc
    • San Diego, California, United States, 92121
      • Pacific Sleep Medicine Services
  • Florida
    • Miami, Florida, United States, 33143
      • Miami Research Associates
    • Naples, Florida, United States, 34110
      • OmniTrials, 11181 Health Park Blvd, Suite 3040
    • Pembroke Pines, Florida, United States, 33026
      • Broward Research Group
    • St Petersburg, Florida, United States, 33707
      • Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548
    • Gainesville, Georgia, United States, 30501
      • Sleep Disorders Center of Georgia - Gainesville
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Assocaites Clinical Research
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Community Research
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Center for Sleep Medicine, 101 Courtney Circle
  • Missouri
    • Chesterfield (St Louis), Missouri, United States, 63017
      • Sleep Medicine and Research Center, 232 S. Woods Mill Road
  • New York
    • New York, New York, United States, 10019
      • Clinilabs, Inc., 423 West 55th Street, 4th Floor
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Cincinnati, Ohio, United States, 45246
      • Tri-State Sleep Disorders Center, 1275 East Kemper Road
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Sleep Disorders Center, 1333 Taylor Street, Suite 5A
  • Texas
    • Dallas, Texas, United States, 75231
      • Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Evotec Neurosciences GmbH
• Investigators: Principal Investigator: James K Walsh, PhD, St Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Study Completion (ACTUAL): July 1, 2007

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (ESTIMATE): November 20, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): January 7, 2008
• Last Update Submitted That Met QC Criteria: January 2, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: 2005