search
Back to results

Efficacy Study of EVT 201 to Treat Insomnia

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EVT 201
Sponsored by
Evotec Neurosciences GmbH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • St Petersburg Sleep Disorders Center
  • The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
  • Vince and Associates Clinical Research
  • St. Luke's Hospital
  • Tri-State Sleep Disorders Center

Outcomes

Primary Outcome Measures

Total Sleep Time
Wake after sleep onset

Secondary Outcome Measures

Latency to persistent sleep
Number of awakenings
Total wake time
Minutes of stages 1-4 and REM sleep
REM latency
Patient reported sleep variables
Residual sedation measures
Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.

Full Information

First Posted
September 22, 2006
Last Updated
January 29, 2008
Sponsor
Evotec Neurosciences GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00380003
Brief Title
Efficacy Study of EVT 201 to Treat Insomnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Evotec Neurosciences GmbH

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
66 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EVT 201
Primary Outcome Measure Information:
Title
Total Sleep Time
Title
Wake after sleep onset
Secondary Outcome Measure Information:
Title
Latency to persistent sleep
Title
Number of awakenings
Title
Total wake time
Title
Minutes of stages 1-4 and REM sleep
Title
REM latency
Title
Patient reported sleep variables
Title
Residual sedation measures
Title
Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Walsh, PhD
Organizational Affiliation
St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Petersburg Sleep Disorders Center
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
St. Luke's Hospital
City
Chesterfield (St Louis)
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tri-State Sleep Disorders Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of EVT 201 to Treat Insomnia

We'll reach out to this number within 24 hrs