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Chronic InsomniaPhase 3NCT00671125

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Chronic Insomnia
What is being tested?
Ramelteon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
405 participants
Where
25 sitesUnited States
Study dates
Jan 2003to Sep 2003
Phase
Phase 3
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Females who are not of childbearing potential must be postmenopausal for 1 year or have history of hysterectomy and/or oophorectomy.
  • Primary insomnia as defined by the DSM-IV-TRTM for at least 3 months and as defined by subjective sleep latency (sSL) greater than or equal to 30 minutes, subjective total sleep time (sTST) less than or equal to 6.5 hours per night, and daytime complaint(s) associated with disturbed sleep.
  • Mean latency of greater than or equal to 20 minutes on 2 consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
  • Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
  • Body mass index between 18 and 34, inclusive.

Who cannot join

  • Known hypersensitivity to Ramelteon or related compounds, including melatonin.
  • Previously participated in a study involving Ramelteon.
  • Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night single-blind study medication, whichever is longer.
  • Sleep schedule changes required by employment (e.g. shift worker) within three months prior to the first night of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
  • Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single blind study medication.
  • Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
Show all 40Show fewer
  • History of psychiatric disorder (including anxiety or depression) within the past 12 months.
  • History of drug addiction or drug abuse within the past 12 months.
  • History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
  • Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single-blind study medication.
  • Uses tobacco products during nightly awakenings.
  • Used melatonin, or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication.
  • Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
  • Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • Positive hepatitis panel.
  • Positive urine drug screen including alcohol at screening or a positive breathalyzer test at each check-in.
  • Apnea hypopnea index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of the polysomnogram screening.
  • Periodic leg movement with arousal index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of polysomnogram screening.
  • Any additional condition(s) that in the Investigator's opinion would:
  • affect sleep/wake function
  • prohibit the subject from completing the study
  • not be in the best interest of the subject.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
  • Anxiolytics
  • Hypnotics
  • Antidepressants
  • Anticonvulsants
  • Sedating H1 antihistamines
  • Systemic steroids
  • Respiratory stimulants (eg, theophylline)
  • Decongestants
  • Over-the-counter and prescription stimulants
  • Over-the-counter and prescription diet aids
  • Central nervous system active drugs (including herbal preparations with central nervous system effects)
  • Narcotic analgesics
  • All beta blockers
  • Melatonin
  • St. John's Wort
  • Kavakava
  • Gingko biloba

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Hot Springs, Arkansas

  • Study site

    Lafayette Hill, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, Nebraska

  • Study site

    Miami, Florida

  • Study site

    New York, New York

  • Study site

    Newton, Massachusetts

  • Study site

    Oakland, California

  • Study site

    Overland Park, Kansas

  • Study site

    Pembroke Pines, Florida

  • Study site

    Plano, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Monica, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Troy, Michigan

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Read the detailed description

Insomnia is characterized by difficulties initiating and maintaining sleep or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.

Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

This study will determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon using polysomnography and subjective measures of sleep. Participation in this study is anticipated to be about 2 months.

Being tested
Ramelteon, Placebo
Keywords
Sleep Disorder, Insomnia, Drug Therapy
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders

What participants receive

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

  • RamelteonDrug

    Also called Rozerem™, TAK-375

    Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.

  • RamelteonDrug

    Also called Rozerem™, TAK-375

    Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.

  • PlaceboDrug

    Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.

Study groups in NCT00671125
Study groupRoleWhat they receive
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
Ramelteon 16 mg QDExperimentalNot described
Receives: Drug: Ramelteon
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Latency to Persistent Sleep.

    Measured: Week 1

Secondary outcomes (11)

  1. Mean Latency to Persistent Sleep.

    Measured: Weeks 3 and 5 or Final Visit

  2. Total Sleep Time.

    Measured: Weeks 1, 3 and 5 or Final Visit

  3. Sleep Efficiency.

    Measured: Weeks 1, 3 and 5 or Final Visit

  4. Awake Time after Persistent Sleep.

    Measured: Weeks 1, 3 and 5 or Final Visit

  5. Number of Awakenings after Persistent Sleep.

    Measured: Weeks 1, 3 and 5 or Final Visit

  6. Subjective Sleep Latency.

    Measured: Weeks 1, 3 and 5 or Final Visit

  7. Subjective Total Sleep Time.

    Measured: Weeks 1, 3 and 5 or Final Visit

  8. Subjective Sleep Quality.

    Measured: Weeks 1, 3 and 5 or Final Visit

  9. Subjective Awake Time.

    Measured: Weeks 1, 3 and 5 or Final Visit

  10. Subjective Number of Awakenings.

    Measured: Weeks 1, 3 and 5 or Final Visit

  11. Subjective Ease of Falling Back to Sleep.

    Measured: Weeks 1, 3 and 5 or Final Visit

Timeline

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

  1. First posted5 May 2008 (estimated)
  2. Study startJan 2003
  3. Primary completionSep 2003
  4. Study completionSep 2003

Resources

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
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671125
Sponsor's protocol ID
01-02-TL-375-021
Other IDs
U1111-1114-8329
Status last verified
Nov 2012
First submitted
1 May 2008
Last updated
12 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • Zammit G, Erman M, Wang-Weigand S, Sainati S, Zhang J, Roth T. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med. 2007 Aug 15;3(5):495-504.

    PubMed 17803013

  • Mini L, Wang-Weigand S, Zhang J. Ramelteon 8 mg/d versus placebo in patients with chronic insomnia: post hoc analysis of a 5-week trial using 50% or greater reduction in latency to persistent sleep as a measure of treatment effect. Clin Ther. 2008 Jul;30(7):1316-23. doi: 10.1016/s0149-2918(08)80056-2.

    PubMed 18691991

  • Osborne, T, Louis, M, Wang-Weigand, S and Jie, Z. Treatment of insomnia in women and the melatonin receptor agonist ramelteon (Rozerem). Women's Health Care: A Practical Journal for Nurse Practitioners. 2008; 7: (6): 24-30

  • Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.

    PubMed 19327100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 25 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 6 inclusion and 40 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 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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. 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?

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?

Mean Latency to Persistent Sleep. (time frame: Week 1). 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 NCT00671125, which also lists 4 linked publications.

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 12 Nov 2012.

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