Clinical Trial for Ceftriaxone in Subjects with ALS

Full Study Summary:

Ceftriaxone is an antibiotic that in the laboratory has been shown to protect motor neurons from a variety of different types of injury. The clinical trial will determine whether ceftriaxone is effective in ALS and its long term safety. A total of 500 eligible people with ALS will be enrolled. 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. There are 60 study sites enrolling patients in the United States and Canada. Study visits occur every 4 weeks, more frequently during the first month of the study.

• Eligibility Criteria

  Gender:

  Female, Male

  Minimum Age:

  18

  Maximum Age:

  N/A

  Min Vital Capacity (% predicted normal):

  60

  Time since Symptom Onset:

  <36 months

  Time since Diagnosis:

  Can participants use Riluzole?

  Yes

  
  

  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. 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).

• Site Contact Information

  Phoenix Neurological Associates
  Nicole Hank / .(JavaScript must be enabled to view this email address) / 602-258-3354 ext 137
  Phoenix, Arizona 85018
  United States

  Barrow Neurological Institute
  Gale Kittle / .(JavaScript must be enabled to view this email address) / 602-406-4792
  Phoenix, Arizona 85013
  United States

  University of California, San Francisco
  San Francisco, California 94117
  United States

  California Pacific Medical Center
  Marguerite Engel / .(JavaScript must be enabled to view this email address) / 415-600-3758
  San Francisco, California 94115
  United States

  University of California, San Francisco- Fresno
  Rebekah Garcia / .(JavaScript must be enabled to view this email address) / 559-459-6399, ext 56399
  Fresno, California 93701
  United States

  University of California, Davis
  Roxana Hupcey / .(JavaScript must be enabled to view this email address) / 916-734-6244
  Davis, California 95819
  United States

  Loma Linda University School of Medicine
  Dharmaseeli (Dee) Moses, RN / .(JavaScript must be enabled to view this email address) / 909-558-2037
  Loma Linda, California 92354
  United States

  Cedars-Sinai Medical Center
  Hope Gruendler, RN / .(JavaScript must be enabled to view this email address) / 310-423-1806
  Los Angeles, California 90048
  United States

  University of California, Irvine - MDA ALS Neuromuscular Center
  Veronica Martin / .(JavaScript must be enabled to view this email address) / 714-456-7760
  Orange, California 92868
  United States

  University of Colorado Health Sciences Center
  Aurora, Colorado 80045
  United States

  Hospital for Special Care
  Lavanya Rajachandran / .(JavaScript must be enabled to view this email address) / 860-612-6349
  New Britain, Connecticut 06053
  United States

  University of Miami School of Medicine
  Miami, Florida 33136
  United States

  Mayo Clinic Jacksonville
  Pam DeSaro / .(JavaScript must be enabled to view this email address) / 904-953-7720
  Jacksonville, Florida 32224
  United States

  Emory University
  Crystal Kelly / .(JavaScript must be enabled to view this email address) / 404-727-1638
  Atlanta, Georgia 30322
  United States

  Georgia Health Sciences University
  Brandy Quarles / .(JavaScript must be enabled to view this email address) / 706-721-2681
  Augusta, Georgia 30912
  United States

  Northwestern University Medical School
  Pat Casey / .(JavaScript must be enabled to view this email address) / 312-695-0774
  Chicago, Illinois 60611
  United States

  Indiana University (Regenstrief Health Center)
  Sandra Guingrich / .(JavaScript must be enabled to view this email address) / 317-630-6103
  Indianapolis, Indiana 46202
  United States

  University of Iowa
  Jeri Sieren / .(JavaScript must be enabled to view this email address) / 319-356-8744
  Iowa City, Iowa 52242
  United States

  University of Kansas Medical Center
  Maureen Walsh / .(JavaScript must be enabled to view this email address) / 913-588-0645
  Kansas City, Kansas 66161
  United States

  University of Kentucky Medical Center
  Samantha Thomas / .(JavaScript must be enabled to view this email address) / 859-218-5062
  Lexington, Kentucky 40536
  United States

  Massachusetts General Hospital
  Michelle Parkinson, RN / .(JavaScript must be enabled to view this email address) / 617-643-6249
  Boston, Massachusetts 02114
  United States

  Lahey Clinic
  Lynne Sullivan / .(JavaScript must be enabled to view this email address) / 781-744-1453
  Burlington, Massachusetts 01805
  United States

  Henry Ford Health System
  Helen Foley, RN / .(JavaScript must be enabled to view this email address) / 313-916-3955
  Detroit, Michigan 48202
  United States

  Saint Mary's Healthcare
  Brian Berryhill / .(JavaScript must be enabled to view this email address) / 616-752-5435
  Grand Rapids, Michigan 49503
  United States

  Wayne State University
  Stacey Masse, RN / .(JavaScript must be enabled to view this email address) / 313-745-6124
  Detroit, Michigan 48201
  United States

  Hennepin County Medical Center (Berman Center)
  Cindy Rohde / .(JavaScript must be enabled to view this email address) / 612-341-7923
  Minneapolis, Minnesota
  United States

  Saint Louis University
  Ann Fann / .(JavaScript must be enabled to view this email address) / 314-977-4868
  Saint Louis, Missouri 63104
  United States

  Washington University
  Julaine Florence, PT / .(JavaScript must be enabled to view this email address) / 314-362-6983
  Saint Louis, Missouri 63110
  United States

  Bryan LGH Medical Center (University of Nebraska)
  Becky Weber / .(JavaScript must be enabled to view this email address) / 402-481-8001
  Lincoln, Nebraska 68506
  United States

  UMDNJ- Robert Wood Johnson School of Medicine
  Barbara Belsh, DPM / .(JavaScript must be enabled to view this email address) / 732-235-7234
  New Brunswick, New Jersey 08901
  United States

  Albany Medical Center
  Anne DeNero / .(JavaScript must be enabled to view this email address) / 518-262-7851
  Albany, New York 12205
  United States

  Cornell Medical Center
  Mona Shahbazi, RN / .(JavaScript must be enabled to view this email address) / 212-774-2361
  New York, New York 10021
  United States

  Columbia University
  Nicole Armstrong / .(JavaScript must be enabled to view this email address) / 212-305-8148
  New York, New York 10032
  United States

  Beth Israel Medical Center (NY)
  Theresa Imperato, RN / .(JavaScript must be enabled to view this email address) / 516-946-5467
  New York, New York 10003
  United States

  SUNY Upstate Medical University
  Katie Markis / .(JavaScript must be enabled to view this email address) / 315-464-4998
  Syracuse, New York 13210
  United States

  Wake Forest University School of Medicine
  Theresa Johnston-Crews, RN / .(JavaScript must be enabled to view this email address) / 336-716-2323
  Winston-Salem, North Carolina 27157
  United States

  Carolinas Medical Center
  Cathleen Stenger / .(JavaScript must be enabled to view this email address) / 704-446-6253
  Charlotte, North Carolina 28203
  United States

  The Cleveland Clinic Foundation
  Nicole Berry / .(JavaScript must be enabled to view this email address) / 216-445-1741
  Cleveland, Ohio 44195
  United States

  Ohio State University
  Amy Barlett / .(JavaScript must be enabled to view this email address) / 614-366-9050
  Columbus, Ohio 43210
  United States

  Oregon Clinic (Providence Clinic)
  Britt Ash / .(JavaScript must be enabled to view this email address) / 503-963-3128
  Portland, Oregon 97213
  United States

  Drexel University College of Medicine (Hahnemann Campus)
  Christine Barr, RN / .(JavaScript must be enabled to view this email address) / 267-507-2633
  Philadelphia, Pennsylvania 19107
  United States

  Pennsylvania State University, Hershey Medical Center
  Beth Stephens / .(JavaScript must be enabled to view this email address) / 717-531-0003 ext 283395
  Hershey, Pennsylvania 17033
  United States

  Allegheny Hospital
  Mary Powell / .(JavaScript must be enabled to view this email address) / 412-359-5075
  Pittsburgh, Pennsylvania 15212
  United States

  University of Pennsylvania
  Mary Kelley, RN / .(JavaScript must be enabled to view this email address) / 215-829-3053
  Philadelphia, Pennsylvania 19107
  United States

  University of Pittsburgh
  Danielle Rowlands, RN / .(JavaScript must be enabled to view this email address) / 412-648-9053
  Pittsburgh, Pennsylvania 15213
  United States

  Medical University of South Carolina
  Michelle DeCandio, RN / .(JavaScript must be enabled to view this email address) / 843-792-9016
  Charleston, South Carolina 29403
  United States

  Vanderbilt University
  Diana Davis, RN / .(JavaScript must be enabled to view this email address) / 615-322-8957
  Nashville, Tennessee 37232
  United States

  Texas Neurology
  Christi Kelly / .(JavaScript must be enabled to view this email address) / 214-827-3610 x 298
  Dallas, Texas 75214
  United States

  Methodist Neurological Institute
  Luis Lay / .(JavaScript must be enabled to view this email address) / 713-441-3057
  Houston, Texas 77030
  United States

  University of Utah Health Sciences Center
  Narneice Craven / .(JavaScript must be enabled to view this email address) / 801-585-7876
  Salt Lake City, Utah 84132
  United States

  University of Virginia
  Kristen Keller / .(JavaScript must be enabled to view this email address) / 434-982-0170
  Charlottesville, Virginia 22908
  United States

  George Washington University
  Angela Kelly, RN / .(JavaScript must be enabled to view this email address) / 202-741-2717
  Washington D.C. 20037
  United States

  Dalhousie University
  Stephanie Reidy / .(JavaScript must be enabled to view this email address) / 902-473-5866
  Halifax,
  Canada

  University of Calgary
  Haneen Omar / .(JavaScript must be enabled to view this email address) / 403-210-7009
  Calgary,
  Canada

  CHUM (Centre Hospitalier de l'Université de Montréal), Notre-Dame Hospital
  Claire Lefebvre / .(JavaScript must be enabled to view this email address) / 514-890-8237
  Montreal,
  Canada

  London Health Sciences Center, University Campus
  Christine Piechowicz / .(JavaScript must be enabled to view this email address) / 519-685-8500 X 34858
  London,
  Canada

  University of Toronto
  Shirley Pham / .(JavaScript must be enabled to view this email address) / 416-480-5618
  Toronto,
  Canada

  Montreal Neurological Institute (McGill University)
  Jo-Wen Wang / .(JavaScript must be enabled to view this email address) / 514-398-1779
  Montreal,
  Canada

  Laval University
  Stephanie Gormley / .(JavaScript must be enabled to view this email address) / 418-649-0252 ext: 3550
  Quebec City,
  Canada

  University of Alberta
  Ramnik Sekhon / .(JavaScript must be enabled to view this email address) / 780-407-2944
  Edmonton,
  Canada

• Study Results

  In July 2012, the DSMB for the NINDS-sponsored clinical trial of ceftriaxone in ALS recommended that based on existing data the trial be stopped because the study was unlikely to reach the pre-determined efficacy criteria. The NINDS leadership concurred. Pre-clinical research identified ceftriaxone as a promising treatment for ALS therefore it was important for people with ALS to find out if the drug could be beneficial in ameliorating the disease. The study used a novel seamless adaptive design. Final analysis and presentation of the results will occur after completion of site monitoring and database lock. The important contributions of patients, their families and the hard work of the investigators and their teams made it possible to implement the trial. While all had hoped for a more positive result, the trial has moved ALS research forward.