InsomniaPhase 3NCT00869167

Ramelteon for Insomnia Comorbid With Asthma

A Phase 3 study testing Ramelteon in people with Insomnia and Asthma, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Insomnia, Asthma
What is being tested?: Ramelteon
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Jun 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ages 18 - 60 with both insomnia and asthma.
Insomnia:
a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,
the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and
at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.
Additional inclusion criteria include: a subjective TST <6.5 h and a subjective SL > 45 min per night; a mean LPS >20 min over 2 consecutive nights by polysomnography (neither night could have been <15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score > 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.

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Asthma will be diagnosed based on suggestive clinical history and either
airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less
bronchodilator-responsive expiratory airflow limitation (if FEV1 < 70% of predicted value or < 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score < 1.5.

Who cannot join

Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI > 15), periodic leg movements (movement arousal index > 15), REM behavior disorder; or circadian sleep-wake disorders
History of cognitive or other neurological disorders;
History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;
Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;
Unstable or serious medical conditions;
Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);

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Shift work or other types of self imposed irregular sleep schedules;
Obesity (BMI > 35 Kg/m2); or
Pregnancy or desire to become pregnant during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Read the detailed description

Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Conditions: Insomnia, Asthma
Being tested: Ramelteon
Medical subject headings: Sleep Initiation and Maintenance Disorders, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RamelteonDrug
Also called Rozerem
melatonin agonist

Study groups in NCT00869167
Study group	Role	What they receive
1: Ramelteon	Experimental	Not described Receives: Drug: Ramelteon
2: Placebo	Placebo comparator	Not described Receives: Drug: Ramelteon

What is being measured

The primary outcome is the main question the study is designed to answer.

Pittsburgh Sleep Quality Index
The change in ISI and PSQI from baseline to end of study will be compared between the two groups.
PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Measured: baseline and post-treatment (at end of 5 weeks)
Insomnia Severity Index
The change in ISI and PSQI from baseline to end of study will be compared between the two groups.
PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Measured: 5 weeks

Secondary outcomes (3)

Daytime Sleepiness (Epworth Sleepiness Scale)
Score of 0-24, with 24 being the most sleepy
Measured: baseline and post-treatment (at end of 5 weeks)
Daytime Performance (Digit Symbol Substitution Test)
DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.
DSST score can range from 0-125, with 125 being the most number correct during the allotted time period.
Measured: baseline and post-treatment (at end of 5 weeks)
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min
Measured: baseline and during treatment period (during 5th week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jun 2009

First posted25 Mar 2009 (estimated)
Study startMar 2008
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00869167
Sponsor's protocol ID: 07-052R
Status last verified: Apr 2013
First submitted: 19 Mar 2009
Last updated: 1 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ramelteon for Insomnia Comorbid With Asthma
ClinicalTrials.gov ID: NCT00869167
Acronym / sponsor ID: 07-052R
Conditions: Insomnia, Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 2 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Takeda
Study start: Mar 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 25 Mar 2009 (estimated)
Results: Posted 29 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Detailed description

Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1: Ramelteon	Experimental	Drug: Ramelteon
2: Placebo	Placebo comparator	Drug: Ramelteon

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Ages 18 - 60 with both insomnia and asthma.
Insomnia:
Additional inclusion criteria include: a subjective TST <6.5 h and a subjective SL > 45 min per night; a mean LPS >20 min over 2 consecutive nights by polysomnography (neither night could have been <15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score > 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.
Asthma will be diagnosed based on suggestive clinical history and either

Key exclusion criteria (9 listed)

Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI > 15), periodic leg movements (movement arousal index > 15), REM behavior disorder; or circadian sleep-wake disorders
History of cognitive or other neurological disorders;
History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;
Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;
Unstable or serious medical conditions;

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
RamelteonAlso: Rozeremmelatonin agonist	Drug	1: Ramelteon, 2: Placebo

Primary outcome

Pittsburgh Sleep Quality Index
Time frame: baseline and post-treatment (at end of 5 weeks)
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Insomnia Severity Index
Time frame: 5 weeks
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms

3 secondary outcomes

Daytime Sleepiness (Epworth Sleepiness Scale)
Time frame: baseline and post-treatment (at end of 5 weeks)
Daytime Performance (Digit Symbol Substitution Test)
Time frame: baseline and post-treatment (at end of 5 weeks)
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min
Time frame: baseline and during treatment period (during 5th week)

Results and safety

Results posted to the registry on 29 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ramelteon	2	2
Placebo	1	0

Primary outcome: Pittsburgh Sleep Quality Index

Time frame: baseline and post-treatment (at end of 5 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Ramelteon n = 2	Placebo n = 0
Value	2 (0)	–

Population analysed: The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.

Primary outcome: Insomnia Severity Index

Time frame: 5 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Ramelteon n = 2	Placebo n = 0
Value	-6.5 (6.36)	–

Population analysed: The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramelteon	0 of 2 (0%)	0 of 2 (0%)	Not reported
Placebo	0 of 1 (0%)	0 of 1 (0%)	Not reported

Limitations and caveats (from the sponsor): Recruitment difficulties led to only 3 participants in the study. Only 2 participants finished the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

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Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
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Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
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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.

Brandon S Lu, MD, MS principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Insomnia and Asthma, run by Northwestern University at 1 site 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pittsburgh Sleep Quality Index (time frame: baseline and post-treatment (at end of 5 weeks)). 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?

On the ClinicalTrials.gov record for NCT00869167.

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 1 May 2013; AzTrials last refreshed its copy on 30 Oct 2026.