A Safety and Efficacy Outpatient Study of TAK-375 in Adults With Chronic Insomnia
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Insomnia
Intervention: TAK-375 (Drug); TAK-375 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Stephen Sainati, MD, PhD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.
Summary
This was a study to evaluate the efficacy and safety of 8 mg TAK-375, 16 mg of TAK-375 or a
placebo taken once daily in adults with chronic insomnia.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary objective of this study was to evaluate the safety and efficacy of TAK-375 at doses of 8 and 16 mg compared to placebo in subjects with chronic insomnia.
Secondary outcome: Objective and subjective measures of efficacy.Evaluation of rebound insomnia and withdrawal from study medication. Evaluation of sleep architecture variables. Evaluation of special safety variables, including sleep architecture, rebound, withdrawal effects, and residual pharmacological effects. Safety variables including adverse events, laboratory tests, vital signs, ECG results, and physical examination findings.
Detailed description:
Subjects who met study criteria reported to the sleep laboratory for a total of 3 sessions of
2 consecutive nights of double-blind study medication and polysomnography (PSG) recordings.
Each subject was randomized to receive 8 mg of TAK-375, 16 mg of TAK-375, or a placebo. On
all other nights, subjects self-administered the assigned study medication nightly at home at
bedtime. After 35 nights of double-blind treatment, subjects reported to the sleep laboratory
for 2 additional, consecutive nights of PSG recordings with single-blind placebo. Throughout
the course of the study, subjects maintained a daily sleep diary during the outpatient period
and returned to the clinic periodically for review of diaries, concomitant medications, and
adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject was a man or woman 18 to 64 years of age, inclusive.
- The subject, if a woman, was nonpregnant and nonlactating.
- The subject had primary insomnia as defined by the DSM-IV-TRTM for at least 3 months
and sSL greater than or equal to 30 minutes, sTST less than or equal to 6. 5 hours per
night, and daytime complaint(s) associated with disturbed sleep.
- The subject had a mean latency to persistent sleep of at least 20 minutes on 2
consecutive PSG 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 2 nights with no less
than 45 minutes a night.
- The subject's habitual bedtime was between 8: 30 PM and 12: 00 AM.
Exclusion Criteria:
- The subject had a known hypersensitivity to TAK-375 or related compounds, including
melatonin.
- The subject had previously participated in a study involving TAK-375.
- The subject had participated in any other investigational study or taken any
investigational drug within 30 days or 5 half-lives (T1/2s) prior to the first night
of single-blind study medication, whichever was longer.
- The subject 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 Initial Screening.
- The subject had 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.
- The subject had a history of seizures, sleep apnea, chronic obstructive pulmonary
disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- The subject had a history of psychiatric disorder (including anxiety or depression)
within the past 12 months.
- The subject had a history of drug addiction or drug abuse within the past 12 months.
- The subject had a history of alcohol abuse within the past 12 months, as defined in
DSM-IV-TRTM, or regularly consumed 4 or more alcoholic drinks per day.
- The subject had a 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 the first night of single-blind
study medication.
- The subject used tobacco products during nightly awakenings.
- The subject had used melatonin, or other drugs or supplements known to affect
sleep/wake function within 1 week (or 5 T1/2s of the drug, whichever was longer) prior
to the first day of single-blind study medication.
- The subject had used any CNS medication within 1 week (or 5 T1/2s of the drug,
whichever is longer) prior to the first day of single-blind study medication. These
medications must not have been used to treat psychiatric disorders.
- The subject intended to continue taking any disallowed medication or any prescription
medication or OTC medication that was known to affect the sleep/wake function or
otherwise interfere with evaluation of the study medication. The subject must have
reported all prescription and OTC medications taken in the 3 weeks prior to Initial
Screening.
- The subject had any clinically important abnormal finding as determined by a medical
history, physical examination, ECG, or clinical laboratory tests, as determined by the
investigator. Subjects with clinically significant abnormal laboratory values being
considered for the study had to be approved by both TPNA and the principal
investigator.
- The subject had a positive hepatitis panel including hepatitis A antibody (only
reactiveIgM was exclusionary), hepatitis B surface antibody, hepatitis B core antibody
(only reactive IgM was exclusionary), hepatitis C antibody, or hepatitis B surface
antigen. Subjects who tested positive for hepatitis B surface antibody were not
excluded if the result was due to vaccination.
- The subject had an apnea hypopnea index (per hour of sleep) greater than 10 as seen on
PSG, on the first night of the PSG Screening.
- The subject had periodic leg movement with arousal index (per hour of sleep) greater
than 10 as seen on PSG, on the first night of PSG Screening.
- The subject had any additional condition(s) that in the investigator's opinion would:
a) affect sleep/wake function, b) prohibit the subject from completing the study, or
c) not be in the best interest of the subject.
Locations and Contacts
Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Hot Springs, Arkansas, United States
San Diego, California, United States
Oakland, California, United States
Santa Monica, California, United States
San Francisco, California, United States
Anaheim, California, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Crestview Hills, Kentucky, United States
Chevy Chase, Maryland, United States
Newton, Massachusetts, United States
Troy, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Lafayette Hill, Pennsylvania, United States
Plano, Texas, United States
Austin, Texas, United States
Additional Information
Starting date: January 2003
Ending date: August 2003
Last updated: May 2, 2008
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