Efficacy Study of EVT 201 to Treat Insomnia

Evotec

Status and phase

Completed

Phase 2

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: EVT 201

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380003

2004

Details and patient eligibility

About

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).

Sex

All

Ages

21 to 64 years old

Volunteers

No Healthy Volunteers

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)