A Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia

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.

The was a safety and efficacy study of TAK-375 at doses of 4 mg and 8 mg compared to placebo in elderly subjects with chronic insomnia for 35 days.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Average subjective sleep latency, per subject diary, from Nights 1 through 7 of double-blind treatment.

Secondary outcome:

Objective and subjective measures of efficacy

Assessment of effects of withdrawal and rebound insomnia.

Safety variables including adverse events, laboratory tests, vital signs, ECG results, and physical exam findings.

Detailed description: Subjects who met the study criteria entered a 35-night, Double-Blind Treatment Period. During the Double-Blind Treatment Period, subjects were randomized to receive TAK-375 4 mg, TAK-375 8 mg, or placebo. This period was followed by a 7-night, Single-Blind Placebo Run-out Period to evaluate possible rebound insomnia and withdrawal effects. Throughout the course of the study, subjects were asked to maintain daily diaries and return to the clinic weekly for Clinical Global Impressions (CGI), and review of sleep diaries, concomitant medications, and adverse events.

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-TRTM 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 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 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 Initial Screening.

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

his/her 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 used tobacco products during nighttime 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 the first day of single-blind study medication.

- The subject had used any CNS medication within 1 week (or 5 half lives 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.

Mobile, Alabama, United States

Muscle Shoals, Alabama, United States

Tallahassee, Alabama, United States

Columbiana, Alabama, United States

Calgary, Alberta, Canada

Medicine Hat, Alberta, Canada

Edmonton, Alberta, Canada

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tempe, Arizona, United States

Little Rock, Arkansas, United States

Hot Springs, Arkansas, United States

North Vancouver, British Columbia, Canada

Irvine, California, United States

Anaheim, California, United States

Northridge, California, United States

Murrieta, California, United States

La Mesa, California, United States

Redlands, California, United States

Oakland, California, United States

Riverside, California, United States

San Diego, California, United States

Spring Valley, California, United States

La Jolla, California, United States

Vista, California, United States

Encinitas, California, United States

Los Angeles, California, United States

Rosemead, California, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Kissimmee, Florida, United States

St. Petersburg, Florida, United States

Longwood, Florida, United States

Safety Harbor, Florida, United States

DeLand, 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

Jacksonville, Florida, United States

West Palm Beach, Florida, United States

Pembroke Pines, Florida, United States

Pinellas Park, Florida, United States

Atlanta, Georgia, United States

Blairsville, Georgia, United States

Macon, Georgia, United States

Chciago, Illinois, United States

Northfield, Illinois, United States

Evansville, Indiana, United States

Wichita, Kansas, United States

Shawnee Mission, Kansas, United States

Louisville, Kentucky, United States

Murray, Kentucky, United States

New Orleans, Louisiana, United States

Winnipeg, Manitoba, Canada

Bethesda, Maryland, United States

Newton, Massachusetts, United States

Brockton, Massachusetts, United States

Belmont, Massachusetts, United States

Detroit, Michigan, United States

Hattiesburg, Mississippi, United States

St. Louis, Missouri, United States

Kansas City, Missouri, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Toms River, New Jersey, United States

Brick, New Jersey, United States

Edison, New Jersey, United States

Albuquerque, New Mexico, United States

Mineola, New York, United States

Great Neck, New York, United States

Williamsville, New York, United States

Manlius, New York, United States

St. John's, Newfoundland and Labrador, Canada

Hickory, North Carolina, United States

Raleigh, North Carolina, United States

Cary, North Carolina, United States

Winston-Salem, North Carolina, United States

Salisbury, North Carolina, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Beachwood, Ohio, United States

Canfield, Ohio, United States

Tulsa, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

North Bay, Ontario, Canada

London, Ontario, Canada

Corunna, Ontario, Canada

Portland, Oregon, United States

Eugene, Oregon, United States

Reading, Pennsylvania, United States

Jenkintown, Pennsylvania, United States

Scotland, Pennsylvania, United States

Parkdale, Prince Edward Island, Canada

Montreal, Quebec, Canada

Warwick, Rhode Island, United States

Anderson, South Carolina, United States

Greer, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Fayetteville, Tennessee, United States

Johnson City, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Fort Worth, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Bellevue, Washington, United States

Gig Harbor, Washington, United States

Madison, Wisconsin, United States

New Berlin, Wisconsin, United States

Starting date: January 2003
Ending date: January 2004
Last updated: May 2, 2008