Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia

NCT00237497 | Completed Phase 3

• 3 other identifiers: TAK-375-EC301U1111-1114-15422004-004350-91
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia

Conditions

Balance

Keywords

Insomnia; Center of Pressure; Postural Sway; Drug Therapy; Balance and Stability

Outcome Measures

Primary Outcomes (1)

• Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Open

  1.5 to 2 hours Postdose on Night 14.

Secondary Outcomes (19)

• Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Closed.

  1.5 to 2 hours Postdose on Night 14.

• Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 1-2).

  Nights 1 and 2.

• Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 27-28).

  Nights 27 and 28.

• Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 1-2).

  Nights 1 and 2.

• Subjective sleep latency Measured by a Post-sleep Questionnaire (Nights 27-28).

  Nights 27 and 28.

Study Arms (3)

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Zopiclone 7.5 mg QD

ACTIVE COMPARATOR

Drug: Zopiclone

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.

Also known as: Rozerem, TAK-375

Ramelteon 8 mg QD

Zopiclone DRUG

Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.

Also known as: Zimovane, Imovane, Rovane

Zopiclone 7.5 mg QD

Placebo DRUG

Placebo-matching tablets, orally, once daily for up to 28 nights.

Placebo QD

Eligibility Criteria

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

You may qualify if:

• Men or women aged 18 to 64 years, inclusive.
• Capable of understanding and willing to comply with the protocol and had to fully understand and sign the informed consent document at screening prior to any study-related procedures being performed.
• In addition, subjects had to meet the following study-specific criteria:
• Chronic insomnia as defined by:
• A complaint of difficulty initiating or maintaining sleep or of nonrestorative sleep that lasted for at least 3 months.
• The sleep disturbance (or associated daytime fatigue) caused clinically significant distress or impairment in social, occupational, or other important areas of functioning.
• The disturbance did not occur exclusively during the course of narcolepsy, breathing related sleep disorder, circadian rhythm sleep disorder or a parasomnia.
• The sleep disturbance did not occur exclusively during the course of another mental disorder (eg, major depressive disorder, generalized anxiety disorder, a delirium).
• The disturbance was not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition.
• Based on sleep history, a subjective sleep latency (sSL) ≥45 minutes.
• Based on sleep history, a subjective total sleep time (sTST) ≤6.5 hours.
• Based on sleep history, a mean LPS of ≥20 minutes on 2 consecutive screening nights with neither night \<15 minutes.
• Based on sleep history, their habitual bedtime was between 10:00 PM and 1:00 AM.
• Able to stand with eyes closed, arms at side and feet apart at hips width for at least 1 minute with out taking a step.
• A body mass index (BMI) between 18 and 34, inclusive.

You may not qualify if:

• A known hypersensitivity to ramelteon, zopiclone 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 5 half-lives prior to the first night of single-blind study medication (whichever was longer).
• Had sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or had flown across greater than 3 time zones within 7 days prior to screening.
• Participated in a weight-loss program or had substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
• A history of, or currently had, conditions that would affect balance such as:
• Orthostatic hypotension.
• Dizziness.
• Vertigo, or benign paroxysmal positional vertigo.
• A history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, periodic leg movement syndrome, or fibromyalgia.
• A history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months.
• A history of drug addiction or drug abuse within the past 12 months.
• A history of alcohol abuse within the past 12 months or regularly consumed more than 14 alcoholic drinks per week or consumed any alcoholic drinks within 24 hours of all polysomnography visits.
• 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.
• Used 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 was longer) prior to the first day of single-blind study medication.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon; zopiclone

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director Clinical Science

  Takeda Global Research & Development Centre (Europe)

  PRINCIPAL INVESTIGATOR

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: October 11, 2005
• First Posted: October 12, 2005
• Study Start: July 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

GB (1)