A Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects 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)
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 study evaluated the safety and efficacy of TAK-375 4 mg for two nights, TAK-375 8 mg for
two nights and a placebo for two nights in elderly subjects with chronic insomnia.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover 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 4 and 8 mg compared to placebo in elderly subjects with chronic insomnia.
Secondary outcome: Subjective and objective measures of efficacy.Sleep architecture variables. Safety variables, including adverse events, laboratory tests, vital signs, ECG results, and physical examination findings.
Detailed description:
Subjects were randomized into a dosing sequence that included 4 and 8 mg of TAK-375 and
placebo. Each treatment period consisted of 2 consecutive nights in a sleep laboratory. All
study medications were administered 30 minutes before lights out. Polysomnography recording
started at subjects' usual bedtimes. After each treatment period, subjects underwent a 5 to
12-day washout period before returning to the clinic and commencing with the next treatment
in the sequence. This was repeated until all treatment periods were completed.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject was a man or a postmenopausal woman.
- The subject had primary insomnia as defined by the DSM-IV-TR™ for at least 3 months
and by 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 of greater than or equal to 20 minutes per PSG on 2
consecutive 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 night
less than 45 minutes.
- 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 Day 1 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 Day 1 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 had substantially altered
their exercise routine within 30 days prior to Day 1 of single-blind study
medication.
- The subject had a history of seizures, sleep apnea, chronic obstructive pulmonary
disease (COPD), 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-TR™, or regularly consumed 4 or more alcoholic drinks per day.
- The subject had an acute clinically significant illness, as determined by the
investigator, within 30 days prior to Day 1 of single-blind study medication.
- 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 Day 1 of single-blind study
medication.
- The subject used tobacco products within 90 days prior to Day 1 of single-blind study
medication.
- The subject had used melatonin, or other drugs or supplements known to affect
sleep-wake function, or had consumed grapefruit or grapefruit juice within 5 days (or
5 T1/2s whichever is longer) prior to Day 1 of single-blind study medication.
- The subject had used any CNS medication within 3 weeks (or 5 T1/2s, of the drug,
whichever was longer) prior to Day 1 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 is 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
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
reactive IgM 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 15 as seen on
PSG, on the first night of the PSG Screening.
- The subject had periodic leg movement (PLM) with arousal index (per hour of sleep)
greater than 20 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:
1) affect sleep-wake function, 2) prohibit the subject from completing the study, or
3) not be in the best interest of the subject to participate in the study.
Locations and Contacts
Hot Springs,, Arkansas, United States
San Diego, California, United States
Irvine, California, United States
Palm Springs, California, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
Miami, Florida, United States
Brandon, Florida, United States
Naples, Florida, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Crestview Hills, Kentucky, United States
Troy, Michigan, United States
St. Louis, Missouri, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Houston, Texas, United States
Additional Information
Starting date: November 2002
Ending date: July 2003
Last updated: May 1, 2008
|
