Trial | NCT00380003  Report issue

Title

Efficacy Study of EVT 201 to Treat Insomnia
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    evt 201 ...

  • Study Participants

    66
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).
Study Started
Sep 30
2006
Study Completion
Apr 30
2007
Last Update
Jan 30
2008
Estimate

Drug EVT 201

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)
No Results Posted