A Safety Study of the Long-Term Administration of TAK-375 in Subjects With Chronic Insomnia

Condition(s) targeted: Chronic Insomnia

Intervention: TAK-375 (Drug); 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.

This was a phase III, open-label, fixed-dose, multicenter study in which 1213 subjects were enrolled and instructed to take TAK-375 nightly for one year.

Official title: A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long-Term Administration of TAK-375 in Subjects With Chronic Insomnia

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The objective of this study was to assess the long-term safety of regular use of TAK-375.

Detailed description: Subjects participating in the study were instructed to take a single oral dose of TAK-375 at bedtime,and to maintain sleep diaries for 1 year. Throughout the study, subjects returned to the clinic for safety assessments (including evaluation of adverse events, concomitant medications, sleep diaries, and menstrual diaries [menstruating women only]). At the end of dosing, subjects completed a 3-night Placebo Run-out Period. All study participants received placebo during this period.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject participated previously in an allowed TAK-375 study and completed all

Final Visit procedures from the previous study within 21 days of the Treatment Initiation Visit for this study.

- The subject, if a woman, was nonpregnant and nonlactating.

- The subject, in the investigator's opinion, required long-term treatment for

insomnia.

- The subject had primary insomnia as defined by the Diagnostic and Statistical Manual

of Mental Disorders, 4th Edition Text Revision (DSM-IV-TR™) for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep.

- 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 participated in any other investigational study, or had taken any

investigational drug within 30 days or 5 half-lives prior to Day 1 of study medication, whichever was longer. The only exception to this was prior participation in an allowed TAK-375 study.

- The subject had sleep schedule changes required by employment (eg, shift worker)

within 3 months prior to Day 1 of study medication, or had flown across greater than 3 time zones within 7 days prior to Screening.

- The subject participated in a weight loss program or had substantially altered their

exercise routine within 30 days prior to Day 1 of study medication.

- The subject had a history of seizures, sleep apnea, chronic obstructive pulmonary

disease, 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 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 half lives of the drug, whichever was longer) prior to Day 1 of study medication.

- The subject had used any CNS medication within 1 week (or 5 half lives of the drug,

whichever was longer) prior to Day 1 of study medication. These medications must not have been used to treat psychiatric disorders.

Mobile, Alabama, United States

Birmingham, Alabama, United States

Tempe, Arizona, United States

Phoenix, Arizona, United States

Hot Springs, Arkansas, United States

Little Rock, Arkansas, United States

Redlands, California, United States

Irvine, California, United States

Anaheim, California, United States

San Diego, California, United States

Northridge, California, United States

Santa Monica, California, United States

Newport Beach, California, United States

Murrieta, California, United States

San Francisco, California, United States

La Mesa, California, United States

La Jolla, California, United States

Burbank, California, United States

Riverside, California, United States

Cerritos, California, United States

Lafayette, California, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Boulder, Colorado, United States

Wheat Ridge, Colorado, United States

Pueblo, Colorado, United States

Wilmington, Delaware, United States

Largo, Florida, United States

Ocala, Florida, United States

Naples, Florida, United States

St. Petersburg, Florida, United States

Stuart, Florida, United States

Edgewater, Florida, United States

Winter Park, Florida, United States

Fort Lauderdale, Florida, United States

Brandon, Florida, United States

Safety Harbor, Florida, United States

New Smyrna Beach, Florida, United States

Deland, Florida, United States

Miami, Florida, United States

Clearwater, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Blairsville, Georgia, United States

Austell, Georgia, United States

Macon, Georgia, United States

Boise, Idaho, United States

Libertyville, Illinois, United States

Chicago, Illinois, United States

Skokie, Illinois, United States

Elk Grove Village, Illinois, United States

Evansville, Indiana, United States

Fort Wayne, Indiana, United States

Shawnee Mission, Kansas, United States

Florence, Kentucky, United States

Paducah, Kentucky, United States

Louisville, Kentucky, United States

Shreveport, Louisiana, United States

New Orleans, Louisiana, United States

Chevy Chase, Maryland, United States

Prince Frederick, Maryland, United States

Baltimore, Maryland, United States

Rockville, Maryland, United States

Bryan Pogue, Maryland, United States

Frederick, Maryland, United States

Newton, Massachusetts, United States

Troy, Michigan, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Hattiesburg, Mississippi, United States

Wentzville, Missouri, United States

St. Louis, Missouri, United States

St. Peters, Missouri, United States

Billings, Montana, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Toma River, New Jersey, United States

Lawrenceville, New Jersey, United States

Clementon, New Jersey, United States

Newark, New Jersey, United States

Brooklyn, New York, United States

Lake Success, New York, United States

Kingston, New York, United States

White Plains, New York, United States

Rochester, New York, United States

Williamsville, New York, United States

Cary, North Carolina, United States

Wilmington, North Carolina, United States

Salisbury, North Carolina, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Beachwood, Ohio, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Dublin, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Bala Cynwyd, Pennsylvania, United States

Lafayette Hill, Pennsylvania, United States

Jenkintown, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Warwick, Rhode Island, United States

Columbia, South Carolina, United States

Anderson, South Carolina, United States

Greer, South Carolina, United States

Bristol, Tennessee, United States

Cordova, Tennessee, United States

Austin, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Fairfax, Virginia, United States

Tacoma, Washington, United States

Oakland, Washington, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Wauwatosa, Wisconsin, United States

Starting date: February 2003
Ending date: January 2004
Last updated: May 1, 2008