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