Efficacy of TAK-375 on Transient Insomnia in Healthy Adults - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00671398

Purpose

This purpose of this study is to evaluate the safety and efficacy of TAK-375 in healthy subjects within a sleep lab.

Condition	Intervention	Phase
Transient Insomnia	Drug: TAK-375 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia

Resource links provided by NLM:

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total Sleep Time. [ Time Frame: Days 1 and 2. ] [ Designated as safety issue: No ]
Sleep Efficiency. [ Time Frame: Days 1 and 2. ] [ Designated as safety issue: No ]
Wake Time after Persistent Sleep Onset. [ Time Frame: Days 1 and 2. ] [ Designated as safety issue: No ]
Number of Awakenings after Persistent Sleep. [ Time Frame: Days 1 and 2. ] [ Designated as safety issue: No ]
Subjective Sleep Latency. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Subjective Total Sleep Time. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Subjective Sleep Quality. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Subjective Wake Time after Sleep Onset. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Subjective Number of Awakenings. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Subjective Ease of Falling Back to Sleep after Awakening. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Stage 1 Nonrapid Eye Movement (NREM) Sleep [ Time Frame: Day 2. ] [ Designated as safety issue: No ]
Stage 2 Nonrapid Eye Movement (NREM) Sleep [ Time Frame: Day 2. ] [ Designated as safety issue: No ]
Stage 3/4 Nonrapid Eye Movement (NREM) Sleep [ Time Frame: Day 2. ] [ Designated as safety issue: No ]
Latency to Rapid Eye Movement (REM) Sleep [ Time Frame: Day 2. ] [ Designated as safety issue: No ]
Percentage of Total Sleep Time in REM Sleep [ Time Frame: Day 2. ] [ Designated as safety issue: No ]

Enrollment:	289
Study Start Date:	December 2002
Study Completion Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Experimental	Drug: TAK-375 TAK-375 8 mg, tablets, orally for one night only.
2.: Experimental	Drug: TAK-375 TAK-375 16 mg, tablets, orally for one night only
3.: Placebo Comparator	Drug: Placebo TAK-375 placebo-matching tablets, orally for one night only

Detailed Description:

Insomnia is characterized by difficulties initiating and maintaining sleep, or of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.

TAK-375 is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

This study is being conducted to evaluate the safety and efficacy of a single dose of TAK-375 in normal healthy subjects in a sleep lab model of transient insomnia. Participation is this study is anticipated to be about 3 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

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.
Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes.
Body mass index between 18 and 34, inclusive.

Exclusion Criteria:

Any history of insomnia.
Spent one or more nights in a sleep laboratory.
Epworth Sleepiness Scale score of greater than 10.
Known hypersensitivity to TAK-375 or related compounds, including melatonin.
Previously participated in a study involving TAK-375.
Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening.
Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day 1.
History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
History of a psychiatric disorder (including anxiety or depression) within the past 12 months.
History of drug addiction or drug abuse within the past 12 months.
Any physical or psychiatric disorder that may be associated with sleep disturbance.
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.
Uses tobacco products during nightly awakenings.
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.
Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in.
Any additional condition(s) that in the investigator's opinion would
- affect sleep-wake function
- prohibit the subject from completing the study
- not be in the best interest of the subject.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
- Anxiolytics
- Hypnotics
- Antidepressants
- Anticonvulsants
- Sedating H1 antihistamines
- Systemic steroids
- Respiratory stimulants (eg, theophylline)
- Decongestants
- Over-the-counter and prescription stimulants
- Over-the-counter and prescription diet aids
- Central nervous system active drugs
- Narcotic analgesics
- All beta blockers
- St. John's Wort
- Kava-kava
- gingko biloba

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671398

Locations

United States, California

San Diego, California, United States

Palm Springs, California, United States
United States, Florida

Miami, Florida, United States

Pembroke Pines, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Kansas

Overland Park, Kansas, United States
United States, New York

New York, New York, United States

Rochester, New York, United States
United States, Ohio

Cincinnati, Ohio, United States

Dublin, Ohio, United States
United States, South Carolina

Columbia, South Carolina, United States
United States, Texas

Houston, Texas, United States

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

VP Clinical Science

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

Rozerem Package Insert This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Publications:

Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J. The effects of ramelteon in a first-night model of transient insomnia. Sleep Med. 2009 Jan;10(1):55-9. Epub 2008 Aug 8.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	01-02-TL-375-023
Study First Received:	May 1, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00671398 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Insomnia
Sleep Disorder
Drug Therapy

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias

Sleep Disorders
Healthy
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 03, 2009