Search Canlyme site Home Symptoms Lyme Chat Group Diagnosis Treatment World-wide Support Finder Books/Video RESEARCH Lymelinks Contact Pets & Lyme DONATIONS Drug Info Medical Dictionary Board of Directors      Click on the graphic to vote for this site as a Starting Point Hot Site. No Warranties or Representations Lyme Disease symptoms vary from person to person. (lymes disease lyme's disease lime disease limes disease) The data and information presented in this web site are presented in good faith and believed to be accurate regarding Lyme disease (commonly misspelled lymes disease lyme's disease lime disease limes disease) and other related diseases. Any and all liability for the content or any omissions including any inaccuracies, errors, or misstatements in such data or information is expressly disclaimed. The web site is compiled for the sole purpose of informing community members of resources and information pertaining to Lyme Borreliosis Disease and its coinfections. Lyme disease symptoms may vary from person to person. The Canadian Lyme Disease Foundation, Directors and members are not liable for any direct or indirect damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action arising out of or in connection with the use or performance of information available from this website. Consult a qualified Lyme ( Borreliosis ) Disease literate doctor for medical advice if Lyme Disease is suspect to discuss your Lymes Disease Symptoms. en français For Physicians Ticks Coinfections Prevention Our Stories Click Here to order our free Lyme Disease Flyer,    Here for our free Lyme Disease Poster ..documents may be copied (to distribute) but edit only for alignment. (http://www.mda.org/research/view_alsctrial.aspx?id=164) (Last Updated 6/26/2009) Neuromuscular Trial/Study DISEASE CLASSIFICATION(S): Amyotrophic Lateral Sclerosis(ALS) Ceftriaxone -- Trial in Subjects with ALS TRIAL UPDATES: June 2009 The first two stages of the clinical trial of ceftriaxone in ALS have been completed. The aim of stage 1 was to determine the pharmacokinetics (way the body absorbs, distributes, metabolizes and excretes a drug) of ceftriaxone at 2 grams and 4 grams per day. The goal of stage 2 was to determine the 20-week safety and tolerability of ceftriaxone. The efficacy portion of the study, called stage 3, has begun, and the study is now enrolling participants at approximately 50 U.S. and four Canadian centers. The aim of this portion of the study is to determine if ceftriaxone prolongs survival and/or slows decline in function. PURPOSE AND RATIONALE: The purpose of the study is to evaluate the safety and effect of intravenous ceftriaxone treatment in amyotrophic lateral sclerosis (ALS). It is known that nerve cells called motor neurons die in the brains and spinal cords of people with ALS. However, the cause of the 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 is an antibiotic (in a class known as “cephalosporins”) that is approved to treat certain types of infections. The investigators involved in this study are interested in studying ceftriaxone because the drug may also 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. STUDY DETAILS: This is a double-blind, placebo-controlled study. This means that neither participants nor investigators will know who is receiving ceftriaxone and who is not; and that a portion of the study participants will receive ceftriaxone, while another portion receive a placebo (an inert substance that looks like the study drug). The third stage of the study, which opened in May 2009, will enroll 540 additional study participants. Participants will have safety laboratory tests throughout the study and their strength and vital capacity will be tested at regular intervals. Because ceftriaxone is in intravenous (IV) medication, participants will also have an intravenous catheter (called a "central venous catheter") placed in a vein in the chest, through which the study medication will be given. The overall study principal investigator is Merit Cudkowicz, M.D., at Massachusetts GeneralHospital. The co-principal Investigators are Swati Aggarwal, M.D., at Massachusetts GeneralHospital, and Jeremy Shefner, M.D., Ph.D., at SUNYUpstateMedicalCenter. OPENING DATES: Jun 1 2006; stage 3 opened May 14, 2009 TARGET NUMBER OF PARTICIPANTS: 540 RECRUITMENT STATUS: Open ELIGIBILITY REQUIREMENTS: Inclusion Criteria Participants must... * have ALS * be at least 18 years old * be medically able to undergo the study procedures * have an FVC (forced vital capacity, a respiratory measurement) of at least 60 percent of normal * have a caregiver who will be available to help with daily study medication administration * live within a reasonable distance of the study site, because of the need for frequent site visits Exclusion Criteria Participants must not ... * be taking any other experimental medications for ALS * have a history of sensitivity to cephalosporin antibiotics (Ancef, Keflex, Ceclor, Ceftin, Lorabid, Suprax and Fortaz are examples) This is not a complete list of eligibility criteria. Please contact your closest study site for detailed information regarding eligibility criteria and study participation. CONTACT INFORMATION: Coordinating Center Fran Murphy, Project Manager Massachusetts General Hospital Neurology Clinical Trials Unit Boston, MA Phone: (617) 643-3980 Email: fmurphy@partners.org US LOCATIONS Arizona Nicole Hank Study Coordinator Phoenix Neurological Associates Phoenix, AZ United States Phone: 602-258-3354 ext. 137 California Jeffrey Rosenfeld MD, PhD Principal Investigator University of California-Fresno, Fresno, CA United States Phone: 559-459-6282 Fizaa Ahmed, Study Coordinator University of California-San Francisco San Francisco, CA United States Phone: 415-514-2510 Roxana Hupcey Study Coordinator University of California-Davis Davis, CA United States Phone: 916-734-6244 Rebecca Alvarez Study Coordinator University of California-Los Angeles Los Angeles, CA United States Phone: 310-794-2557 Veronica Martin Study Coordinator University of California-Irvine Orange, CA United States Phone: 714-456-7760 Shirley Paulose Study Coordinator Stanford University School of Medicine Stanford, CA United States Phone: 315-464-5004 Dharmaseeli (Dee) Moses RN, Study Coordinator Loma Linda University School of Medicine Loma Linda, CA United States Phone: 909-558-2037 Benjamin Scott, Study Coordinator Cedars-Sinai Medical Center Los Angeles, CA United States Phone: 310-423-5152 Marguerite Engel, Study Coordinator California Pacific Medical Center San Francisco, CA United States Phone: 415-600-3758 Colorado Elizabeth Whitethorn Study Coordinator University of Colorado Health Sciences Center Aurora, CO United States Phone: 303-724-2186 District of Columbia Elizabeth Kingery RN, Study Coordinator George Washington University Washington, DC Phone: 202-741-2717 Florida Donald Koggan, Study Coordinator University of Miami School of Medicine Miami, FL Phone: 305-243-7424 Pam DeSaro, Study Coordinator Mayo Clinic-Jacksonville Jacksonville, FL Phone: 904-953-7720 Georgia Demetric Hillman, Study Coordinator Medical College of Georgia Augusta, GA Phone: 706-721-2681 Meraida Polak RN, Study Coordinator Emory University Atlanta, GA Phone: 404-778-3754 Illinois Pat Casey, Study Coordinator Northwestern University Medical School Chicago, IL Phone: 312-695-0774 Indiana Sandra Guingrich LPN, Study Coordinator Indiana University (Regenstrief Health Center) Indianapolis, IN Phone: 317-630-6103 Kansas Maureen Walsh, Study Coordinator University of Kansas Medical Center Kansas City, KS Phone: 913-588-0645 Kentucky Kathie Vanderpool RN, Study Coordinator University of Kentucky Medical Center Lexington, KY Phone: 859-218-5064 Massachusetts Alison Goldenberg, Study Coordinator Massachusetts General Hospital Boston, MA Phone: 617-643-6249 Alyssa DeThomas, Study Coordinator Lahey Clinic Burlington, MA Phone: 781-744-2958 Michigan Stacey Masse RN, Study Coordinator Wayne State University Detroit, MI Phone: 313-745-6124 Karen Burritt RN, Study Coordinator Saint Mary's Healthcare Grand Rapids, MI Phone: 616-493-9727 Joyce Jones RN, Study Coordinator Henry Ford Health System Detroit, MI Phone: 313-916-4561 Minnesota Cindy Rohde, Study Coordinator Hennepin County medical Center (Berman Center) Minneapolis, MN Phone: 612-341-7923 Missouri Julaine Florence, Study Coordinator Washington University St. Louis, MO Phone: 314-362-6983 Susan Eller RN, Study Coordinator St. Louis University St. Louis, MO Phone: 314-977-4867 North Carolina Theresa Johnston-Crews RN, Study Coordinator Wake Forest University School of Medicine Winston-Salem, NC Phone: 336-716-2323 Sheryl Holmes RN, Study Coordinator Carolinas Medical Center Charlotte, NC Phone: 704-446-6208 Nebraska June Smith, Study Coordinator Bryan LGH Medical Center (University of Nebraska) Lincoln, NE Phone: 402-481-3967 New Jersey Barbara Belsh, Study Coordinator Robert Wood Johnson School of Medicine (UMDNJ) New Brunswick, NJ Phone: 732-235-7340 New York Suzanne Alterman RN, Study Coordinator Upstate Neurology Albany, NY Phone: 518-533-1546 Mary Lou Watson, Study Coordinator SUNY Upstate Medical University Syracuse, NY Phone: 315-464-5004 Mona Shahbazi RN, Study Coordinator Cornell Medical Center New York, NY Phone: 212-774-2361 Daniel Bell, Study Coordinator Columbia University New York, NY Phone: 212-305-8148 Theresa Imperato RN, Study Coordinator Beth Israel Medical Center New York, NY Phone: 516-946-5467 Ohio Nicole Berry, Study Coordinator Cleveland Clinic Foundation Cleveland, OH Phone: 216-445-1741 Amy Bartlett, Study Coordinator Ohio State University Columbus, OH Phone: 614-366-9050 Oregon Shiralynn Moore, Study Coordinator Oregon Clinic (Providence Clinic) Portland, OR Phone: 503-963-3128 Pennsylvania Danielle Rowlands RN, Study Coordinator University of Pittsburgh Pittsburgh, PA Phone: 412-648-9053 Laura Klenke-Borgmann RN, Study Coordinator University of Pennsylvania Philadelphia, PA Phone: 215-829-5041 Beth Stephens, Study Coordinator Pennsylvania state University, Hershey Medical Center Hershey, PA Phone: 717-531-0003 (ext. 283395) Christine Barr RN, Study Coordinator Drexel University College of Medicine (Hahnemann Campus) Philadelphia, PA Phone: 215-762-5186 Sherry Patuc, Study Coordinator Allegheny Hospital Pittsburgh, PA Phone: 412-359-8644 Tennessee Diana Davis RN, Study Coordinator Vanderbilt University Nashville, TN Phone: 615-322-8957 Texas Shari Hand, Study Coordinator Texas Neurology Dallas, TX Phone: 214-279-0326 Luis Lay, Study Coordinator Methodist Neurological Institute Houston, TX Phone: 713-441-3057 Utah Summer Davis, Study Coordinator University of Utah Health Sciences Center Salt Lake City, UT Phone: 801-585-9055 Virginia Kristen Keller, Study Coordinator University of Virginia Charlottesville, VA Phone: 434-982-0170 Vermont University of Vermont College of Medicine Burlington, VT CANADA Jane McKinley, Study Coordinator University of Toronto Toronto, Ontario Phone: 416-480-6860 Ann Rowe, Study Coordinator London Health Sciences Center, University Campus London, Ontario Phone: 519-663-3934 Claire Lefebvre, Study Coordinator CHUM (Centre Hospitalier de l'Universite de Montrreal), Notre Dame Hospital Montreal, Quebec Phone: 514-890-8237 Jo-Wen Wang, Study Coordinator Montreal Neurological Institute (McGill University) Montreal, Quebec Phone: 514-398-1779 TOP