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

Evotec

Status and phase

Completed

Phase 2

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: EVT 201

Study type

Interventional

Funder types

Industry

Identifiers

NCT00401284

2005

Details and patient eligibility

About

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.

Enrollment

135 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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