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

This study has been completed.
Sponsor:
Information provided by:
Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:
NCT00401284
First received: November 17, 2006
Last updated: January 2, 2008
Last verified: January 2008

November 17, 2006
January 2, 2008
November 2006
Not Provided
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
Same as current
Complete list of historical versions of study NCT00401284 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
Drug: EVT 201
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
July 2007
Not Provided

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00401284
2005
Not Provided
Not Provided
Evotec Neurosciences GmbH
Not Provided
Principal Investigator: James K Walsh, PhD St Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
Evotec Neurosciences GmbH
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP