Efficacy Study of EVT 201 to Treat Insomnia
This study is currently recruiting patients. Verified by Evotec Neurosciences GmbH February 2007
Sponsored by: Evotec Neurosciences GmbH Information provided by: Evotec Neurosciences GmbH ClinicalTrials.gov Identifier: NCT00380003 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 II MedlinePlus related topics: Sleep Disorders
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment 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 Further study details as provided by Evotec Neurosciences GmbH:Primary Outcomes: Total Sleep Time; Wake after sleep onset Secondary Outcomes: 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. Expected Total Enrollment: 66 Study start: September 2006; Expected completion: August 2007
Eligibility Ages Eligible for Study: 21 Years - 64 Years, Genders Eligible for Study: Both CriteriaInclusion 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) Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00380003
Florida St Petersburg Sleep Disorders Center, St Petersburg, Florida, 33707, United States; Recruiting Neil T Feldman, MD 727-360-0853 stpetesdc@aol.com Neil T Feldman, MD, Principal Investigator
Georgia The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548, Atlanta, Georgia, 30342, United States; Recruiting Alan Lankford, PhD 404-257-0080 Ext. 115 alankfod@sleepsciences.com Alan Lankford, PhD, Principal Investigator
Kansas Vince and Associates Clinical Research, Overland Park, Kansas, 66212, United States; Recruiting Steven Hull, MD 913-696-1601 tgoodwin@vinceandassociates.com Steven Hull, MD, Principal Investigator
Missouri St. Luke's Hospital, Chesterfield (St Louis), Missouri, 63017, United States; Recruiting G'Ann Scott 314-542-4930 elligq@stlo.mercy.net James K Walsh, PhD, Principal Investigator
Ohio Tri-State Sleep Disorders Center, Cincinnati, Ohio, 45246, United States; Recruiting Martin Scharf, PhD 513-671-3102 mscharf@tristatesleep.com Martin Scharf, PhD, Principal Investigator
Study chairs or principal investigators James K Walsh, PhD, Principal Investigator, St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI More Information Study ID Numbers: 2004 Last Updated: February 2, 2007 Record first received: September 22, 2006 ClinicalTrials.gov Identifier: NCT00380003 Health Authority: United States: Food and Drug Administration ClinicalTrials.gov processed this record on 2007-02-05
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