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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380003

Enrollment

Registered

2006-09-25

Start date

2006-09-30

Completion date

2007-04-30

Last updated

2008-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Initiation and Maintenance Disorders

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).

Interventions

DRUGEVT 201

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to 64 Years

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)

Design outcomes

Primary

Measure	Time frame
Total Sleep Time	—
Wake after sleep onset	—

Secondary

Measure	Time frame
Total wake time	—
Minutes of stages 1-4 and REM sleep	—
REM latency	—
Latency to persistent sleep	—
Residual sedation measures	—
Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.	—
Patient reported sleep variables	—
Number of awakenings	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026