Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia

NCT00756002 | Completed Phase 3 Results

• 3 other identifiers: 01-06-TL-375-0812007-000403-15U1111-1115-2084
• Study Type: interventional
• Target: 259
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Chronic Insomnia; DIMS (Disorders of Initiating and Maintaining Sleep); Disorders of Initiating and Maintaining Sleep; Insomnia Disorder Sleep Initiation Dysfunction; Transient Insomnia; Drug Therapy; Sleep Disorders, Intrinsic

Outcome Measures

Primary Outcomes (1)

• Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).

  Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.

  Nights 1-2

Secondary Outcomes (44)

• Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).

  Nights 15-16

• Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).

  Nights 29-30

• Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).

  Nights 1-2

• Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).

  Nights 15-16

• Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).

  Nights 29-30

Study Arms (2)

Ramelteon 4 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.

Also known as: Rozerem™, TAK-375

Ramelteon 4 mg QD

Placebo DRUG

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

Placebo QD

Eligibility Criteria

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

You may qualify if:

• A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study.
• Has a body mass index between 18 and 34, inclusive.
• Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
• The predominant complaint is difficulty initiating or maintaining sleep, or non-restorative sleep, for at least 3 months.
• The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
• The sleep disturbance does not occur exclusively during the course of narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or parasomnia.
• The disturbance does not occur exclusively during the course of another mental disorder (eg, major depressive disorder, generalized anxiety disorder, delirium).
• The disturbance is not due to the direct physiological effects of a substance or a general medical condition.
• Based on sleep history, the subject reports a history of subjective sleep latency ≥45 minutes and a subjective total sleep time ≤6.5 hours for at least 3 months.
• Based on sleep history, the subject's habitual bedtime is between 10:00 PM and 1:00 AM.
• On at least 3 of the first 5 nights of single blind run-in placebo treatment, the subject must have an subjective sleep latency of ≥45 minutes and a subjective total sleep time of \<6.5 hours.
• The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in must be ≤30 minutes.
• The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in must be ≤30 minutes.
• The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in must be ≤30 minutes.
• Is willing to have a fixed bedtime and agrees to go to bed within ± 30 minutes of the habitual bedtime during the entire study, exceptions will be allowed at weekends that are not within 2 days of a polysomnography visit.

You may not qualify if:

• Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
• Has participated in a study involving ramelteon within 6 months of initial Screening Visit.
• Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first night of single-blind study medication.
• Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or has flown across greater than 3 time zones within 7 days prior to Screening.
• Has participated in a weight loss program or has substantially altered his or her exercise routine within 30 days prior to the first night of single-blind study medication.
• Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movements during sleep, chronic obstructive pulmonary disease, fibromyalgia, schizophrenia, bipolar disorder, mental retardation or a cognitive disorder.
• Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months.
• Has a history of drug addiction or alcohol abuse and/or regularly consumes 4 or more alcoholic drinks per day within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.
• Has a current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single blind study medication.
• The subject uses tobacco products (including nicotine gum and patch) during nightly awakenings.
• The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
• The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Anxiolytics
• Central nervous system active drugs (including herbal)
• Hypnotics

Sponsors & Collaborators

• Takeda: lead

Related Links

• Rozerem Package Insert.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic

Interventions

ramelteon

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sr VP, Clinical Science
• Organization: Takeda Global Research & Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: September 17, 2008
• First Posted: September 19, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 2, 2010
• Results First Posted: November 5, 2009

Record last verified: 2010-05