Efficacy Study of EVT 201 to Treat Insomnia

This study has been completed.
Sponsor:
Information provided by:
Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:
NCT00380003
First received: September 22, 2006
Last updated: January 29, 2008
Last verified: January 2008
  Purpose

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).


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: EVT 201
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Evotec Neurosciences GmbH:

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.

Estimated Enrollment: 66
Study Start Date: September 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380003

Locations
United States, Florida
St Petersburg Sleep Disorders Center
St Petersburg, Florida, United States, 33707
United States, Georgia
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, United States, 30342
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Missouri
St. Luke's Hospital
Chesterfield (St Louis), Missouri, United States, 63017
United States, Ohio
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States, 45246
Sponsors and Collaborators
Evotec Neurosciences GmbH
Investigators
Principal Investigator: James K Walsh, PhD St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00380003     History of Changes
Other Study ID Numbers: 2004
Study First Received: September 22, 2006
Last Updated: January 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014