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Completed

NCT Number: NCT00380003

Efficacy Study of EVT 201 to Treat Insomnia

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).

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Petersburg Sleep Disorders Center, St. Petersburg, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EVT 201

Drug

Primary outcomes

  1. Total Sleep Time

  2. Wake after sleep onset

Secondary outcomes

  1. Latency to persistent sleep

  2. Number of awakenings

  3. Total wake time

  4. Minutes of stages 1-4 and REM sleep

  5. REM latency

  6. Patient reported sleep variables

  7. Residual sedation measures

  8. Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.

Sponsors and collaborators

Lead sponsor

Evotec Neurosciences GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Sep 25, 2006
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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