Sleep Initiation and Maintenance DisordersPhase 2NCT00259311
Efficacy Study of LY2422347 to Treat Insomnia
A Phase 2 study testing LY2422347 in people with Sleep Initiation and Maintenance Disorders, run by Eli Lilly and Company at 22 sites in United States.
Trial summary
The purpose of this study is to determine whether a compound known as LY2422347 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 24 to 75 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- LY2422347
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 22 sitesUnited States
- Study dates
- Nov 2005to Nov 2006
- 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 24 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have been diagnosed with primary insomnia
- must not be significantly overweight
- must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day
- must be able to read and speak in English and be able to see well enough to use the handheld electronic device
- the patient's answer to the question "During the past month, how would you rate your sleep quality overall?" must be either "Very Bad" or "Fairly Bad"
Who cannot join
- cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD)
- cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination
- cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep
- cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Anaheim, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Atlanta, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brooklyn, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Burbank, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chattanooga, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cincinnati, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City of Saint Peters, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cleveland, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Columbia, South Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Crestview Hills, Kentucky
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fairfax, Virginia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pismo Beach, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tampa, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Topeka, Kansas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Whiting, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winston-Salem, North Carolina
About this study
Official title: A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia
The purpose of this study is to determine whether a compound known as LY2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).
- Being tested
- LY2422347, placebo
- 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.
LY2422347Drug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measure will be Wakening After Sleep Onset (WASO)
Secondary outcomes (8)
Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
improvement of daily subjective sleep quality at endpoint
reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
Clinician Global Impression of Improvement (CGI-I) score at endpoint
improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
Safety and tolerability of LY2422347 compared with placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startNov 2005
- Study completionNov 2006
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.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- 400 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259311
- Sponsor's protocol ID
- 9951
- Other IDs
- H9U-MC-MDBD
- Status last verified
- Jan 2007
- First submitted
- 28 Nov 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00259311
- Acronym / sponsor ID
- 9951
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Nov 2006
- First posted
- 29 Nov 2005 (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 LY2422347 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
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 24 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- must have been diagnosed with primary insomnia
- must not be significantly overweight
- must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day
- must be able to read and speak in English and be able to see well enough to use the handheld electronic device
- the patient's answer to the question "During the past month, how would you rate your sleep quality overall?" must be either "Very Bad" or "Fairly Bad"
Key exclusion criteria (4 listed)
- cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD)
- cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination
- cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep
- cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
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 |
|---|---|---|
| LY2422347 | Drug | – |
| placebo | Drug | – |
Primary outcome
The primary efficacy measure will be Wakening After Sleep Onset (WASO)
8 secondary outcomes
Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
improvement of daily subjective sleep quality at endpoint
reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
Clinician Global Impression of Improvement (CGI-I) score at endpoint
improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
Safety and tolerability of LY2422347 compared with placebo
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 26 Jan 2007.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 LY2422347 in people with Sleep Initiation and Maintenance Disorders, run by Eli Lilly and Company 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 4 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 26 Jan 2007. 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?
The primary efficacy measure will be Wakening After Sleep Onset (WASO). 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 26 Jan 2007.