Efficacy Study of EVT 201 to Treat Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380003
• Other study ID #: 2004
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2006
• Last updated: January 29, 2008
• Start date: September 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• Source: Evotec Neurosciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

• must have a diagnosis of primary insomnia

• over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours

• must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period

• must be willing and able to complete a sleep diary and questionnaires

Exclusion Criteria:

• must not have a clinically significant or unstable medical condition that may interfere with sleep

• must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder

• must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants

• must not intentionally nap 3 (or more) times per week

• must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• EVT 201

Locations

Country	Name	City	State
United States	The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548	Atlanta	Georgia
United States	St. Luke's Hospital	Chesterfield (St Louis)	Missouri
United States	Tri-State Sleep Disorders Center	Cincinnati	Ohio
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	St Petersburg Sleep Disorders Center	St Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Evotec Neurosciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time
Primary	Wake after sleep onset
Secondary	Latency to persistent sleep
Secondary	Number of awakenings
Secondary	Total wake time
Secondary	Minutes of stages 1-4 and REM sleep
Secondary	REM latency
Secondary	Patient reported sleep variables
Secondary	Residual sedation measures
Secondary	Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.