Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Study Purpose:
The objective of this study is to compare two combinations of drugs, minocycline and creatine or celecoxib and creatine, in a Phase II trial designed to determine which combination is more effective for ALS.
Study Type:
Interventional; Phase II
SEE BELOW FOR PATIENT RECRUITMENT/ENROLLMENT INFORMATION
Study Design:
Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study
Study Details:
Primary Outcomes: ALS Functional Rating Scale Revised (ALSFRS-R) completed monthly during trial.
Secondary Outcomes: Forced Vital Capacity, Quality of Life, Timed Get Up and Go performed monthly. Survival and measures of safety throughout the trial.
Expected Total Enrollment: 120
Study start: July 2006
Principal Investigator: Paul H Gordon, MD, Columbia University
Study Overview:
This trial has several unique features. First, it compares the neuroprotective potential of two combinations of agents that impact multiple mechanisms of cell death. The combinations of minocycline/creatine and celecoxib/creatine are the only agents that have had additive effects in the mouse model of ALS, reducing neurodegeneration and prolonging survival more than individual agents alone. Second, it uses an important new phase II selection trial design to determine which combination is superior. Not only does this trial test combination therapy, but there is no placebo, so everyone who enrolls in the trial will receive active treatment.
Study Location and Contact Information:
General Contacts:
Carolyn Doorish, BA, 212-305-2027, cd2141@columbia.edu
Kate Bednarz, RD, 212-305-1677, keb2114@columbia.edu
Site Contacts:
Arizona
Phoenix Neurological Associates, Phoenix, Arizona, 85006, United States
Recruiting Contact: Lynne Flynn, 602-258-2863, lynneflynn@pnal.net
Todd Levine, MD, Principal Investigator
California
California Pacific Medical Center, San Francisco, California, 94115, United States
Recruiting Contact: Terence Santos, 415-600-3758, santost@sutterhealth.org
Robert G Miller, MD, Principal Investigator
UCLA, Los Angeles, California, 90095, United States
Recruiting Contact: Rebecca Alvarez, 310-825-9816, RRALvarez@mednet.ucla.edu
Michael Graves, MD, Principal Investigator
University of California Irvine, Orange, California, 92868, United States
Recruiting Contact: Veronica Martin, 714-456-7760, vero@uci.edu
Tahseen Mozaffar, MD, Principal Investigator
Florida
Mayo Clinic Florida, Jacksonville, Florida, 32224, United States
Recruiting Contact: Anne Evans, 904-953-7720, evans.anne@mayo.edu
Kevin Boylan, MD, Principal Investigator
Georgia
Medical College of Georgia, Augusta, Georgia, 30912, United States
Recruiting Contact: Lesley Edmonds, 706-721-2681, LEDMONDS@mail.mcg.edu
Michael Rivner, MD, Principal Investigator
Illinois
University of Illinois, Chicago, Illinois, 60637, United States
Recruiting Contact: Judy Richman, 312-413-8605, judyg@uic.edu
Julie Rowan, MD, Principal Investigator
Kansas
University of Kansas, Kansas City, Kansas, 66160, United States
Recruiting Contact: Maureen Walsh, 913-588-0645, mwalsh@kumc.edu
Richard Barohn, MD, Principal Investigator
Minnesota
Mayo Clinic Rochester, Rochester, Minnesota, 55905, United States
Recruiting Contact: Cindy Stoppel, 507-266-0761, Stoppel.Cynthia@mayo.edu
Eric Sorenson, MD, Principal Investigator
Missouri
Washington University, St. Louis, Missouri, 63110, United States
Recruiting Contact: Barb Abrams, 314-747-8288, abramsb@neuro.wustl.edu
Alan Pestronk, MD, Principal Investigator
New Jersey
UMDNJ, New Brunswick, New Jersey, 08901, United States
Recruiting Contact: Barbara Belsh, 732-235-7340, belshba@umdnj.edu
Jerry Belsh, MD, Principal Investigator
New Mexico
University of New Mexico, Albuquerque, New Mexico, 87131, United States
Recruiting Contact: Jeannie Boyle, 505-272-3342, jboyle@salud.unm.edu
John Chapin, MD, Principal Investigator
New York
Beth Israel, New York, New York, 10003, United States;
Recruiting Contact: Theresa Imperato, 212-844-8490, imperato@als-ny.org
Steven Scelsa, MD, Principal Investigator
Columbia University, New York, New York, 10032, United States
Recruiting Contact: Carolyn Doorish, 212-305-2027, cd2141@columbia.edu
Kate Bednarz, 212-305-1677, keb2114@columbia.edu
Paul H Gordon, MD, Principal Investigator
North Carolina
Duke University, Durham, North Carolina, 27705, United States
Recruiting Contact: Karen Grace, 919-668-2844, karen.grace@duke.edu
Richard Bedlack, MD, Principal Investigator
Oregon
Oregon Health and Science University, Portland, Oregon, 97201, United States
Recruiting Contact: Sarah Johnson, 503-494-5236, johnssar@ohsu.edu
Jau-Shin Lou, MD, Principal Investigator
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19107, United States
Recruiting Contact: Mary Kelley, 215-829-3053, kelleym@pahosp.com
Leo McCluskey, MD, Principal Investigator
Texas
UT Southwestern Medical Center, Dallas, Texas, 75390, United States
Recruiting Contact: Barbi Estes, 214-648-7976, Barbi.Estes@utsouthwestern.edu
Jaya Trivedi, MD, Principal Investigator
Vermont
University of Vermont, Burlington, Vermont, 05405, United States
Recruiting Contact: Shannon Lenox, 802-656-3876, Shannon.Lenox@med.uvm.edu
Rup Tandan, MD, Principal Investigator
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