Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

NCT00247390 | Completed Phase 3

• 3 other identifiers: TAK-375-EC3022004-004351-20U1111-1114-3231
• Study Type: interventional
• Target: 451
• Locations: 9 countries
• Sites: 48

Brief Summary

The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia; Sleep Initiation and Maintenance Disorder; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Mean change in Latency to Persistent Sleep of 2-night polysomnogram.

  Months 3 and 6 or Final Visit

Secondary Outcomes (11)

• Mean change in Total Sleep Time from polysomnogram, on 2 nights over 6 months.

  Week 1 and Months 1, 3, 5 and 6 or Final Visit

• Mean change in Subjective Sleep Latency by postsleep questionnaire on 2 nights over 6 months.

  Week 1 and Months 1, 3, 5 and 6 or Final Visit

• Mean change in Subjective Total Sleep Time by postsleep questionnaire on 2 nights over 6 months.

  Week 1 and Months 1, 3, 5 and 6 or Final Visit

• Mean change in Subjective Number of Awakenings by postsleep questionnaire.

  Week 1 and Months 1, 3, 5 and 6 or Final Visit

• Mean change in Subjective Sleep Quality by postsleep questionnaire.

  Week 1 and Months 1, 3, 5 and 6 or Final Visit

Study Arms (2)

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.

Also known as: Rozerem, TAK-375

Ramelteon 8 mg QD

Placebo DRUG

Ramelteon placebo-matching tablets, orally, once daily for up to 42 weeks.

Placebo QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Body mass index between 18 and 34, inclusive.
• Based on sleep history, has had chronic insomnia for at least 3 months.
• Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min and a subjective total sleep time less than or equal to 6.5 hours.
• Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
• Mean latency to persistent sleep of greater than 20 minutes on two 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.
• Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

You may not qualify if:

• Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
• Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
• Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
• Flown across greater than three time zones within 7 days prior to or during screening.
• Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication.
• Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia.
• History of psychiatric disorder within the past 6 months.
• History of alcohol abuse within the past 12 months, as defined in Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits.
• History of drug abuse within the past 12 months, as defined in Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition Revised.
• Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
• Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
• Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
• Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits.
• Positive breathalyzer test on any of the polysomnogram assessment visits.
• Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings.

Sponsors & Collaborators

• Takeda: lead

Study Sites (48)

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Birmingham, Alabama, United States

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Hot Springs, Arkansas, United States

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Los Angeles, California, United States

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Oakland, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Chevy Chase, Maryland, United States

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Lincoln, Nebraska, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Adelaide, Australia

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Camperdown, Australia

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Melbourne, Australia

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Victoria, Australia

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Brussels, Belgium

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Edegem, Belgium

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České Budějovice, Czechia

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Ostrava-Poruba, Czechia

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Prague, Czechia

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Espoo, Finland

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Helsinki, Finland

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Turku, Finland

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Bron, France

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Clamart, France

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Garches, France

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Paris, France

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Rouffach, France

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Berlin, Germany

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Göttingen, Germany

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Hamburg, Germany

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Münster, Germany

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Schwalmstadt, Germany

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Schwerin, Germany

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Milan, Italy

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Irkutsk, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Yekateringburg, Russia

Location

Related Publications (2)

• Mayer G, Wang-Weigand S, Roth-Schechter B, Lehmann R, Staner C, Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep. 2009 Mar;32(3):351-60. doi: 10.1093/sleep/32.3.351.

  PMID: 19294955 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: 19327100 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Medical Director 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

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: November 1, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 3, 2010

Record last verified: 2010-06

Locations

AU (4); CZ (3); BE (2); DE (6); FR (5); FI (3); RU (5); IT (1); US (19)