Clinical Trial for Ceftriaxone in Subjects with ALS

Study Purpose:

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Not enrolling

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Merit Cudkowicz MD, MSc (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

NCT00349622

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital
Sarah Titus / .(JavaScript must be enabled to view this email address) / (617) 726-1398
.(JavaScript must be enabled to view this email address) 149 13th Street
Charlestown, Massachusetts 02129 United States

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.

Study Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Participant Duration:

52 weeks after last subject is enrolled.

Estimated Enrollment:

500

Estimated Study Start Date:

05/31/2009

Estimated Study Completion Date:

10/31/2011

Posting Last Modified Date:

10/31/2011

Date Study Added to alsconsortium.org:

10/14/2011
  • 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.