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Trial record 1 of 2 for:    EVT 201
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Efficacy Study of EVT 201 to Treat Insomnia

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ClinicalTrials.gov Identifier: NCT00380003
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : January 30, 2008
Sponsor:
Information provided by:
Evotec Neurosciences GmbH

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: EVT 201 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : September 2006
Actual Study Completion Date : April 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Total Sleep Time
  2. Wake after sleep onset

Secondary Outcome Measures :
  1. Latency to persistent sleep
  2. Number of awakenings
  3. Total wake time
  4. Minutes of stages 1-4 and REM sleep
  5. REM latency
  6. Patient reported sleep variables
  7. Residual sedation measures
  8. Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT00380003     History of Changes
Other Study ID Numbers: 2004
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008

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