Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

NCT00671294 | Completed Phase 3

• 2 other identifiers: 01-02-TL-375-017U1111-1114-8272
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 18

Brief Summary

This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.

Conditions

Chronic Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (1)

• Mean latency to persistent sleep of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period.

  Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.

Secondary Outcomes (10)

• Total Sleep Time.

  Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.

• Sleep Efficiency.

  Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.

• Wake Time after Sleep Onset.

  Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.

• Number of Awakenings after Persistent Sleep Onset.

  Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.

• Subjective Sleep Latency.

  Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.

Study Arms (1)

Ramelteon and Placebo QD (9 possible combinations total)

EXPERIMENTAL

Drug: Ramelteon and Placebo (9 possible combinations total)

Interventions

Ramelteon and Placebo (9 possible combinations total) DRUG

Randomized sequence over two consecutive nights for a total of three treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights

Also known as: Ramelteon, Rozerem, TAK-375

Ramelteon and Placebo QD (9 possible combinations total)

Eligibility Criteria

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

You may qualify if:

• Male or a post-menopausal female.
• Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision for at least 3 months and as defined by subjective sleep latency greater than or equal to 30 minutes, subjective total sleep time 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 per polysomnography 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.
• 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 Day 1 of single-blind study medication, whichever is longer.
• Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 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 Day 1 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.
• Had an acute clinically significant illness, as determined by the investigator, within 30 days prior to Day 1 of single-blind study medication.
• Current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to Day 1 of single-blind study medication.
• Used tobacco products within 90 days prior to Day 1 of single-blind study medication.
• Used melatonin, or other drugs or supplements known to affect sleep/wake function, or has consumed grapefruit or grapefruit juice within 5 days (or 5 half lives, whichever is longer) prior to Day 1 of single-blind study medication.
• Used any central nervous system medication within 3 weeks (or 5 half lives of the drug, whichever is longer) prior to Day 1 of singleblind 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (18)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Irvine, California, United States

Location

Unknown Facility

Palm Springs, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Brandon, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Naples, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Crestview Hills, Kentucky, United States

Location

Unknown Facility

Troy, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Related Publications (2)

• Roth T, Seiden D, Wang-Weigand S, Zhang J. A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia. Curr Med Res Opin. 2007 May;23(5):1005-14. doi: 10.1185/030079907x178874.

  PMID: 17519067 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

• 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: October 1, 2002
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (18)