Clinical Trial Ceftriaxone in Subjects With ALS

Condition(s) targeted: Amyotrophic Lateral Sclerosis; ALS

Intervention: ceftriaxone (Drug); placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Merit Cudkowicz, MD, MSc., Principal Investigator, Affiliation: Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital

Overall contact:
Amy Swartz, PT, DPT, Phone: (617) 643-3980, Email: fmurphy@partners.org

The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).

Official title: Clinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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

Primary outcome:

Survival.

ALSFRS-R.

Secondary outcome:

vital capacity

evaluation of multiple upper extremity muscles using hand held dynamometry

quality of life

long-term safety and tolerability of ceftriaxone.

Detailed description: It is known that nerve cells called motor neurons die in the brains and spinal cords of people with amyotrophic lateral sclerosis (ALS). However, the cause of this cell death is unknown. Researchers think that increased levels of a chemical called "glutamate" may be related to the cell death. For this reason researchers want to study drugs that decrease glutamate levels near nerves. Ceftriaxone—a semi-synthetic, third generation cephalosporin antibiotic—may increase the level of a protein that decreases glutamate levels near nerves. Studies of ceftriaxone in the laboratory suggest that it may protect motor neurons from injury.

Ceftriaxone is approved by the U. S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Also, ceftriaxone has not been given to people over a long period of time, such as months or years. The goals of this study are to evaluate the safety and effectiveness of ceftriaxone as a treatment for ALS, and to determine the safety and effectiveness of long-term use of the drug in people with ALS.

A total of 600 eligible people with ALS will be enrolled in this multi-center research study. Participants will be randomly assigned to receive treatment with ceftriaxone (2/3 of participants) or placebo (1/3 of participants) for at least 12 months.

The study consists of three stages. The first stage, which has completed enrollment, will look at whether ceftriaxone enters the cerebrospinal fluid (the fluid that surrounds the spinal cord, also called CSF) in amounts that are high enough to be of possible benefit. The second stage, which has also completed enrollment, will look at the safety and side effects of the study drug when taken daily for at least 20 weeks. The third stage, which will begin enrollment in Spring 2009, will determine whether the study drug prolong survival and slows decline in function due to ALS.

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

Criteria:

Inclusion Criteria:

- Participants will be people with ALS, at least 18 years of age.

- Participants must be medically able to undergo the study procedures and have a

caregiver or other individual who will be available to help with daily study medication administration.

- Participants should live within a reasonable distance of the study site, due to

frequent study visits.

Exclusion Criteria:

- Participants cannot be taking any other experimental medications for ALS, or have a

history of sensitivity to cephalosporin antibiotics (such as Ancef, Keflex, Ceclor, Ceftin, Lorabid, Suprax, or Fortaz).

Amy Swartz, PT, DPT, Phone: (617) 643-3980, Email: fmurphy@partners.org

Phoenix Neurological Associates, Phoenix, Arizona 85018, United States; Recruiting
Nicole Hank, Phone: 602-258-3354, Ext: 137
Todd Levine, MD, Principal Investigator

California Pacific Medical Center, San Francisco, California 94115, United States; Recruiting
Marguerite Engel, Phone: 415-600-3758
Jonathan Katz, MD, Principal Investigator

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Hope Gruendler, RN, Phone: 310-423-1806
Evgeny Tsimerinov, MD, Principal Investigator

Loma Linda University School of Medicine (CA), Loma Linda, California 92354, United States; Recruiting
Dharmaseeli (Dee) Moses, RN, Phone: 909-558-2037
Laura Nist, MD, Principal Investigator

Stanford University School of Medicine, Palo Alto, California 94305, United States; Recruiting
Shirley Paulose, Phone: 315-464-5004
S. Charles Cho, MD, Principal Investigator

University of California, Irvine - MDA ALS Neuromuscular Center, Orange, California 92868, United States; Recruiting
Veronica Martin, Phone: 714-456-7760
Tahseen Mozaffar, MD, Principal Investigator

University of California, Los Angeles, Los Angeles, California 90095, United States; Recruiting
Rebecca Alvarez, Phone: 310-794-2557
Michael Graves, MD, Principal Investigator

University of California, Davis, Davis, California 95819, United States; Recruiting
Roxana Hupcey, Phone: 916-734-6244
Bjorn Oskarsson, MD, Principal Investigator

University of California, San Francisco, San Francisco, California 94117, United States; Recruiting
Fizaa Ahmed, Phone: 415-514-2510
Catherine Lomen-Hoerth, MD, Principal Investigator

University of California, San Francisco- Fresno, Fresno, California 93701, United States; Recruiting
Jeffrey Rosenfeld, Phone: 559-459-6282
Jeffrey Rosenfeld, MD, PhD, Principal Investigator

University of Colorado Health Sciences Center, Aurora, Colorado 80045, United States; Recruiting
Elizabeth Whitehorn, Phone: 303-724-2186
Yvonne Rollins, MD, PhD, Principal Investigator

George Washington University, Washington, District of Columbia 20037, United States; Recruiting
Elizabeth Kingery, RN, Phone: 202-741-2717
Elham Bayat, MD, Principal Investigator

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States; Recruiting
Pam DeSaro, Phone: 904-953-7720
Kevin Boylan, MD, Principal Investigator

University of Miami School of Medicine, Miami, Florida 33136, United States; Recruiting
Donald Koggan, Phone: 305-243-7424
Ashok Verma, MD, Principal Investigator

ALS Center at Emory University, Atlanta, Georgia 30322, United States; Recruiting
Meraida Polak, RN, Phone: 404-778-3754, Email: mpolak@emory.edu
Jonathan Glass, MD, Principal Investigator

Medical College of Georgia, Augusta, Georgia 30912, United States; Recruiting
Demetric Hillman, Phone: 706-721-2681
Michael Rivner, MD, Principal Investigator

Northwestern University Medical School, Chicago, Illinois 60611, United States; Recruiting
Pat Casey, Phone: 312-695-0774
Robert Sufit, MD, Principal Investigator

Indiana University (Regenstrief Health Center), Indianapolis, Indiana 46202, United States; Recruiting
Sandra Guingrich, Phone: 317-630-6103, Email: sguingri@iupui.edu
Robert Pascuzzi, MD, Principal Investigator

University of Kansas Medical Center, Kansas City, Kansas 66161, United States; Recruiting
Victoria Watts, RN, Phone: 913-588-0645
Richard Barohn, MD, Principal Investigator

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States; Recruiting
Kathie Vanderpool, RN, Phone: 859-218-5064
Edward Kasarskis, MD, PhD, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Alison Goldenburg, Phone: 617-643-6249
William David, MD, PhD, Principal Investigator

Lahey Clinic, Burlington, Massachusetts 01805, United States; Recruiting
Alyssa DeThomas, Phone: 781-744-2958
James Russell, DO, Principal Investigator

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Joyce Jones, RN, Phone: 313-916-4561
Daniel Newman, MD, Principal Investigator

Saint Mary's Healthcare, Grand Rapids, Michigan 49503, United States; Recruiting
Karen Burritt, RN, Phone: 616-493-9727
Deborah Gelinas, MD, Principal Investigator

Wayne State University, Detroit, Michigan 48201, United States; Recruiting
Stacey Masse, RN, Phone: 313-745-6124
Richard Lewis, MD, Principal Investigator

Hennepin County Medical Center (Berman Center), Minneapolis, Minnesota 55404, United States; Recruiting
Cindy Rohde, Phone: 612-341-7923
Ezgi Tiryaki, MD, Principal Investigator

Washington University, St. Louis, Missouri 63110, United States; Recruiting
Julaine Florence, PT, Phone: 314-362-6983, Email: florencej@neuro.wustl.edu
Alan Pestronk, MD, Principal Investigator

St. Louis University, St. Louis, Missouri 63104, United States; Recruiting
Susan Eller, RN, Phone: 314-977-4867
Ghazala Hayat, MD, Principal Investigator

Bryan LGH Medical Center (University of Nebraska), Lincoln, Nebraska 68506, United States; Recruiting
June Smith, Phone: 402-481-3967
Gary Pattee, MD, Principal Investigator

UMDNJ- Robert Wood Johnson School of Medicine, New Brunswick, New Jersey 08901, United States; Recruiting
Barbara Belsh, DPM, Phone: 732-235-7340
Jerry Belsh, MD, Principal Investigator

SUNY Upstate Medical University, Syracuse, New York 13210, United States; Recruiting
Mary Lou Watson, RRT, Phone: 315-464-5004, Email: watsonma@upstate.edu
Francine Vriesendorp, MD, Principal Investigator

Beth Israel Medical Center (NY), New York, New York 10003, United States; Recruiting
Theresa Imperato, RN, Phone: 516-946-5467
Stephen Scelsa, MD, Principal Investigator

Columbia University, New York, New York 10032, United States; Recruiting
Daniel Bell, Phone: 212-305-8148
Jinsy Andrews, MD, Principal Investigator

Upstate Neurology (NY), Albany, New York 12205, United States; Recruiting
Suzanne Alterman, RN, Phone: 518-533-1546
James Wymer, MD, Principal Investigator

Cornell Medical Center, New York, New York 10021, United States; Recruiting
Mona Shahbazi, RN, Phone: 212-774-2361
Dale Lange, MD, Principal Investigator

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, United States; Recruiting
Theresa Johnston-Crews, RN, Phone: 336-716-2323, Email: tjcrews@wfubmc.edu
James Caress, MD, Principal Investigator

Carolinas Medical Center, Charlotte, North Carolina 28203, United States; Recruiting
Sheryl Holmes, RN, Phone: 704-446-6208
Elena Bravver, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Amy Barlett, Phone: 614-366-9050
John Kissel, MD, Principal Investigator

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Nicole Berry, Phone: 216-445-1751
Erik Pioro, MD, PhD, Principal Investigator

London Health Sciences Center, University Campus, London, Ontario, Canada; Recruiting
Ann Rowe, Phone: 519-663-3934
Christen Shoesmith, MD, Principal Investigator

University of Toronto, Toronto, Ontario, Canada; Recruiting
Jane McKinley, RN, Phone: 416-480-6860
Lorne Zinman, MD, Principal Investigator

Oregon Clinic (Providence Clinic), Portland, Oregon 97213, United States; Recruiting
Shiralynn Moore, Phone: 503-963-3128
Kimberly Goslin, MD, Principal Investigator

Allegheny Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Phyllis Wanetick, RN, Phone: 412-359-8867
Sandeep Rana, MD, Principal Investigator

Drexel University College of Medicine (Hahnemann Campus), Philadelphia, Pennsylvania 19107, United States; Recruiting
Christine Barr, RN, Phone: 215-762-5186
Terry Heiman-Patterson, MD, Principal Investigator

Pennsylvania State University, Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Beth Stephens, Phone: 717-531-0003, Ext: 283395
Zachary Simmons, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19107, United States; Recruiting
Laura Klenke-Borgmann, RN, Phone: 215-829-5041
Leo McCluskey, MD, Principal Investigator

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Danielle Rowlands, RN, Phone: 412-648-9053
David Lacomis, MD, Principal Investigator

Montreal Neurological Institute (McGill University), Montreal, Quebec, Canada; Recruiting
Jo-Wen Wang, Phone: 514-398-1779
Angela Genge, MD, Principal Investigator

CHUM (Centre Hospitalier de l'Université de Montréal), Notre-Dame Hospital, Montreal, Quebec, Canada; Recruiting
Claire Lefebvre, Phone: 514-890-8237
Monique D'Amour, MD, Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Diana Davis, RN, Phone: 615-322-8957
Peter Donofrio, MD, Principal Investigator

Methodist Neurological Institute, Houston, Texas 77030, United States; Recruiting
Luis Lay, Phone: 713-441-3057
Ericka Simpson, MS, Principal Investigator

Texas Neurology, Dallas, Texas 75214, United States; Recruiting
Shari Hand, CCRC, Phone: 214-279-0326
Daragh Heitzman, MD, Principal Investigator

University of Utah Health Sciences Center, Salt Lake City, Utah 84132, United States; Recruiting
Narneice Craven, Phone: 801-585-7876
Mark Bromberg, MD, Principal Investigator

University of Vermont College of Medicine, Burlington, Vermont 05405, United States; Recruiting
Rup Tandan, MD, FRCP, Principal Investigator

University of Virginia, Charlottesville, Virginia 22908, United States; Recruiting
Kristen Keller, Phone: 434-982-0170
Lawrence Phillips, MD, Principal Investigator

Northeast ALS Consortium website

Starting date: July 2006
Ending date: March 2012
Last updated: July 21, 2009