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 insomina for 7 weeks.
Inclusion Criteria:
- The subject was a man or women 18 to 64 years of age, inclusive.
- The subject, if women, was nonpregnant and nonlactating.
- The subject had primary insomnia as defined by the DSM-IV-TRTM for at least 3 months
and a history of daytime complaint(s) associated with disturbed sleep.
- The subject had a sSL greater than or equal to 45 minutes and a sTST less than or
equal to 6. 5 hours per night for at least 3 nights during the week of the Single-Blind
Lead-in Period, based on subject diary.
- 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 day 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 day of single-blind study medication, or had flown
across greater than 3 time zones within 7 days prior to Screening.
- The subject had participated in a weight loss program or has substantially altered
their exercise routine within 30 days prior to the first day of single-blind study
medication.
- The subject had a history of seizures, sleep apnea, chronic obstructive pulmonary
disease (COPD), restless leg syndrome, 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
the 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 day of single-blind study
medication.
- The subject used tobacco products during nighttime wakenings.
- 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 was 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 over-the counter 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 over-the-counter medications taken in the 3
weeks prior to 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 anti-hepatitis A virus (only IgM
was exclusionary), anti- hepatitis B surface [except in subjects who had received
hepatitis B virus vaccination], hepatitis B surface antigen, anti-hepatitis B core
(only IgM was exclusionary), or anti-hepatitis C virus.
- 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.
Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Mesa, Arizona, United States
Little Rock, Arkansas, United States
Hot Springs, Arkansas, United States
Irvine, California, United States
Anaheim, California, United States
Chula Vista, California, United States
Northridge, California, United States
Newport Beach, California, United States
La Mesa, California, United States
Redlands, California, United States
Oakland, California, United States
Spring Valley, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
St. Petersburg, Florida, United States
Longwood, Florida, United States
Safety Harbor, Florida, United States
Hollywood, Florida, United States
Clearwater, Florida, United States
Vero Beach, Florida, United States
Winter Park, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Pembroke Pines, Florida, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Blairsville, Georgia, United States
Marietta, Georgia, United States
Macon, Georgia, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Arlington Heights, Illinois, United States
Evansville, Indiana, United States
Danville, Indiana, United States
Shawnee Mission, Kansas, United States
Bethesda, Maryland, United States
Brockton, Massachusetts, United States
Detroit, Michigan, United States
Hattiesburg, Mississippi, United States
St. Louis, Missouri, United States
Lawrenceville, New Jersey, United States
Moorestown, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
Williamsville, New York, United States
Raleigh, North Carolina, United States
Cary, North Carolina, United States
Winston-Salem, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Sellersville, Pennsylvania `, United States
Altoona, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Johnson City, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Virginia Beach, Virginia, United States
Norfolk, Virginia, United States
Gig Harbor, Washington, United States
