Sleep Initiation and Maintenance DisordersPhase 2NCT00380003
Efficacy Study of EVT 201 to Treat Insomnia
A Phase 2 study testing EVT 201 in people with Sleep Initiation and Maintenance Disorders, run by Evotec Neurosciences GmbH at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- EVT 201
- How many people
- 66 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, 30342
St. Luke's Hospital
Chesterfield (St Louis), Missouri, 63017
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45246
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
St Petersburg Sleep Disorders Center
St. Petersburg, Florida, 33707
About this study
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
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).
- Being tested
- EVT 201
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT 201Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Wake after sleep onset
Secondary outcomes (8)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- Evotec Neurosciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James K Walsh, PhD, Principal investigator, St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380003
- Sponsor's protocol ID
- 2004
- Status last verified
- Jan 2008
- First submitted
- 22 Sep 2006
- Last updated
- 30 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00380003
- Acronym / sponsor ID
- 2004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- Evotec Neurosciences GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVT 201 | Drug | – |
Primary outcome
Total Sleep Time
Wake after sleep onset
8 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James K Walsh, PhD principal investigator
St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVT 201 in people with Sleep Initiation and Maintenance Disorders, run by Evotec Neurosciences GmbH at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.