Sleep Initiation and Maintenance DisordersPhase 2NCT00401284
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
A Phase 2 study testing EVT 201 in people with Sleep Initiation and Maintenance Disorders, run by Evotec Neurosciences GmbH at 22 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 elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- EVT 201
- How many people
- 135 participants
- Where
- 22 sitesUnited States
- Study dates
- Nov 2006to Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of primary insomnia according to DSM-IV
- Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- A history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night
- Able to attend the Sleep Center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period
- Willing and able to complete a sleep diary and questionnaires
Who cannot join
- Clinically significant or unstable medical condition that may interfere with sleep
- Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder
- History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening
- History of substance abuse
- Disorders that interfere with drug pharmacokinetics
- History of cancer, except basal cell carcinoma
Show all 15Show fewer
- Use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of Parkinson's disease such as dopamine agonists and L-dopa (e.g., Sinemet, Madopar or Requip)
- Use of hypnotics within the 2 weeks preceding the Screening Period or within five half-lives of the medication, whichever is longer
- Consuming ≥ 350 mg per day of xanthine-containing food or beverages
- Smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours)
- Body mass index > 34 kg/m2;
- Performing night work or rotating shift work during the past month
- Traveling across > 3 time zones in the past 2 weeks
- Participation in another trial of an investigational product or device within the previous 30 days
- Known allergy or sensitivity to benzodiazepines
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, 30342
Sleep Medicine and Research Center, 232 S. Woods Mill Road
Chesterfield (St Louis), Missouri, 63017
Community Research
Cincinnati, Ohio, 45227
Tri-State Sleep Disorders Center, 1275 East Kemper Road
Cincinnati, Ohio, 45246
Sleep Disorders Center, 1333 Taylor Street, Suite 5A
Columbia, South Carolina, 29201
Community Research
Crestview Hills, Kentucky, 41017
Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125
Dallas, Texas, 75231
Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive
Durham, North Carolina, 27710
Sleep Disorders Center of Georgia - Gainesville
Gainesville, Georgia, 30501
Center for Sleep Medicine, 101 Courtney Circle
Hattiesburg, Mississippi, 39402
Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344
Houston, Texas, 77030
Pacific Sleep Medicine Services Inc
Los Angeles, California, 90048
Miami Research Associates
Miami, Florida, 33143
OmniTrials, 11181 Health Park Blvd, Suite 3040
Naples, Florida, 34110
Clinilabs, Inc., 423 West 55th Street, 4th Floor
New York, New York, 10019
Vince and Assocaites Clinical Research
Overland Park, Kansas, 66212
Broward Research Group
Pembroke Pines, Florida, 33026
PsyPharma Clinical Research Inc.
Phoenix, Arizona, 85050
Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive
Providence, Rhode Island, 02906
Pacific Sleep Medicine Services
San Diego, California, 92121
Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S
St. Petersburg, Florida, 33707
PsyPharma Clinical Research, Inc.
Tucson, Arizona, 85712
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
- 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.
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
Secondary outcomes (9)
Mean Multiple Sleep Latency Test at Day 8
Mean Psychomotor Vigilance Task at Day 8
Mean Karolinska Sleepiness Scale at Day 8
Mean Rey Auditory Verbal Learning Test at Day 8
Mean Profile of Mood State at Day 8
Polysomnography derived variables averaged over nights 1, 6 and 7
Patient reported evaluations of sleep quality and quantity over nights 1 to 7
Benzodiazepine withdrawal questionnaire at baseline and follow-up
Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startNov 2006
- Study completionJul 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 135 participants (estimated)
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
- NCT00401284
- Sponsor's protocol ID
- 2005
- Status last verified
- Jan 2008
- First submitted
- 17 Nov 2006
- Last updated
- 7 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness
- ClinicalTrials.gov ID
- NCT00401284
- Acronym / sponsor ID
- 2005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Evotec Neurosciences GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Nov 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 elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Diagnosis of primary insomnia according to DSM-IV
- Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- A history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night
- Able to attend the Sleep Center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period
- Willing and able to complete a sleep diary and questionnaires
Key exclusion criteria (15 listed)
- Clinically significant or unstable medical condition that may interfere with sleep
- Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder
- History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening
- History of substance abuse
- Disorders that interfere with drug pharmacokinetics
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
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
9 secondary outcomes
Mean Multiple Sleep Latency Test at Day 8
Mean Psychomotor Vigilance Task at Day 8
Mean Karolinska Sleepiness Scale at Day 8
Mean Rey Auditory Verbal Learning Test at Day 8
Mean Profile of Mood State at Day 8
Polysomnography derived variables averaged over nights 1, 6 and 7
Patient reported evaluations of sleep quality and quantity over nights 1 to 7
Benzodiazepine withdrawal questionnaire at baseline and follow-up
Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study
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 7 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
22 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 22 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 5 inclusion and 15 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 7 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 22 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?
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7. 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 7 Jan 2008.