NCT00671125

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

8 months

First QC Date

May 1, 2008

Last Update Submit

November 8, 2012

Conditions

Chronic Insomnia

Keywords

Sleep DisorderInsomniaDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Mean Latency to Persistent Sleep.

    Week 1

Secondary Outcomes (11)

  • Mean Latency to Persistent Sleep.

    Weeks 3 and 5 or Final Visit

  • Total Sleep Time.

    Weeks 1, 3 and 5 or Final Visit

  • Sleep Efficiency.

    Weeks 1, 3 and 5 or Final Visit

  • Awake Time after Persistent Sleep.

    Weeks 1, 3 and 5 or Final Visit

  • Number of Awakenings after Persistent Sleep.

    Weeks 1, 3 and 5 or Final Visit

  • +6 more secondary outcomes

Study Arms (3)

Ramelteon 8 mg QD

EXPERIMENTAL
Drug: Ramelteon

Ramelteon 16 mg QD

EXPERIMENTAL
Drug: Ramelteon

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RamelteonDRUG

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

Also known as: Rozerem™, TAK-375
Ramelteon 8 mg QD
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Oakland, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Crestview Hills, Kentucky, United States

Location

Unknown Facility

Chevy Chase, Maryland, United States

Location

Unknown Facility

Newton, Massachusetts, United States

Location

Unknown Facility

Troy, Michigan, United States

Location

Unknown Facility

Lincoln, Nebraska, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Lafayette Hill, Pennsylvania, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Related Publications (4)

  • 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.

    PMID: 17803013RESULT

  • 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.

    PMID: 18691991RESULT

  • 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

    RESULT

  • 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.

    PMID: 19327100RESULT

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • VP Clinical Science

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 5, 2008

Study Start

January 1, 2003

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

US(25)