Clinical trial NCT00401284: Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Evotec International GmbH
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
Secondary outcomes:
measure: Mean Multiple Sleep Latency Test at Day 8
measure: Mean Psychomotor Vigilance Task at Day 8
measure: Mean Karolinska Sleepiness Scale at Day 8
measure: Mean Rey Auditory Verbal Learning Test at Day 8
measure: Mean Profile of Mood State at Day 8
measure: Polysomnography derived variables averaged over nights 1, 6 and 7
measure: Patient reported evaluations of sleep quality and quantity over nights 1 to 7
measure: Benzodiazepine withdrawal questionnaire at baseline and follow-up
measure: Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: PsyPharma Clinical Research Inc.
state: Arizona
city: Tucson
country: United States
facility: PsyPharma Clinical Research, Inc.
state: Arizona
city: Los Angeles
country: United States
facility: Pacific Sleep Medicine Services Inc
state: California
city: San Diego
country: United States
facility: Pacific Sleep Medicine Services
state: California
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Naples
country: United States
facility: OmniTrials, 11181 Health Park Blvd, Suite 3040
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: St Petersburg
country: United States
facility: Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S
state: Florida
city: Atlanta
country: United States
facility: The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548
state: Georgia
city: Gainesville
country: United States
facility: Sleep Disorders Center of Georgia - Gainesville
state: Georgia
city: Overland Park
country: United States
facility: Vince and Assocaites Clinical Research
state: Kansas
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Hattiesburg
country: United States
facility: Center for Sleep Medicine, 101 Courtney Circle
state: Mississippi
city: Chesterfield (St Louis)
country: United States
facility: Sleep Medicine and Research Center, 232 S. Woods Mill Road
state: Missouri
city: New York
country: United States
facility: Clinilabs, Inc., 423 West 55th Street, 4th Floor
state: New York
city: Durham
country: United States
facility: Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Tri-State Sleep Disorders Center, 1275 East Kemper Road
state: Ohio
city: Providence
country: United States
facility: Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
state: Rhode Island
city: Columbia
country: United States
facility: Sleep Disorders Center, 1333 Taylor Street, Suite 5A
state: South Carolina
city: Dallas
country: United States
facility: Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344
state: Texas
Study officials:
affiliation: St Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
name: James K Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: