A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
The primary objective of study was to determine whether armodafinil treatment at a dose of
150 mg/day is more effective than placebo treatment in reducing fatigue in patients
receiving taxane chemotherapy alone or in combination with other agents by comparing the
change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily
rating of their worst fatigue severity during the past 24 hours. In addition, the change in
the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were
to be recorded.
Key
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire
Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.
Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)
No
Sponsor's Medical Expert
Study Director
Cephalon
United States: Food and Drug Administration
C10953/2036/ON/US
NCT00825227
December 2008
February 2010
Name | Location |
---|---|
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Chester County Hospital | West Chester, Pennsylvania 19380 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Medical College of Georgia | Augusta, Georgia 30912 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
Scripps Cancer Center | La Jolla, California 92037 |
Hematology Oncology Centers of the Northern Rockies | Billings, Montana 59101 |
Frederick Memorial Hospital | Frederick, Maryland 21701 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Iowa Blood and Cancer Care PLC | Cedar Rapids, Iowa 52402 |
Charleston Hematology Oncology, PA | Charleston, South Carolina 29403 |
Forsyth Regional Cancer Center | Winston-Salem, North Carolina 27103 |
Northwest Alabama Cancer Center | Muscle Shoals, Alabama 35661 |
McLeod Cancer and Blood Center | Johnson City, Tennessee 37604 |
Compassionate Cancer Center | Fountain Valley, California 92708 |
Southeastern Gynecologic Oncology, LLC | Atlanta, Georgia 30342 |
Park Nicollet Institute | St Louis Park, Minnesota 55416 |
Saint Joseph Medical Center | Burbank, California 91505 |
Sparta Cancer Center | Sparta, New Jersey 07871 |
Augusta Oncology | Augusta, Georgia 30901 |
Wilshire Oncology | La Verne, California 91750 |
Summit Cancer Center | Savannah, Georgia 31405 |
Ingalls Cancer Research Center | Harvey, Illinois 60426 |
Montana Cancer Institute | Missoula, Montana 59802 |
C. Michael Jones | Germantown, Tennessee 38138 |
Cancer Outreach Assoc. / Outreach Clinical Trial Consortium | Abingdon, Virginia 24211 |