Sleep Initiation and Maintenance Disorders
Conditions
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.
Interventions
DRUGEVT 201
Sponsors
Evotec Neurosciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Mean Multiple Sleep Latency Test at Day 8 | — |
| 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 | — |
| Polysomnography derived variables averaged over nights 1, 6 and 7 | — |
Countries
United States
Outcome results
None listed