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http://www.druglib.com/trial/22/NCT00349622.html
Here's the info:
Clinical Trial Ceftriaxone in Subjects With ALS
Information source: National Institute of Neurological Disorders and Stroke (NINDS) Information obtained from ClinicalTrials.gov on October 22, 2007 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis; ALS
Intervention: ceftriaxone (Drug)
Phase: Phase 3
Enrollment status: Recruiting
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Official(s) and/or principal investigator(s): Merit Cudkowicz, MD, MSc., Principal Investigator, Affiliation: Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital Jeremy Shefner, MD, PhD, Affiliation: Professor of Neurology, State University of New York, Syracuse, Co-Investigator Allitia DiBernardo, MD, Affiliation: Lecturer in Neurology, Harvard Medical School, Massachusetts General Hospital, Co-Investigator
Overall contact: Amy Swartz, PT, MS, Phone: (617) 643-3980, Email: fmurphy@partners.org
Summary The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).
Clinical Details Official title: Clinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Primary outcome: Survival.
Secondary outcome:
ALSFRS-R 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 or placebo for at least 12 months. The study consists of three stages. The first stage will find out if ceftriaxone enters the cerebrospinal fluid (fluid that surrounds the spinal cord, also called CSF) in amounts that are high enough to be of possible benefit. The second stage will look at the safety and side effects of the study drug when taken daily for 16 weeks. The third stage will try to find out whether the study drug helps people with ALS live longer. Sixty participants will take part in stages 1 and 2 and will continue on to stage 3. An additional 540 participants will take part in stage 3.
Duration of the study for participants varies from 1 to 5 years, and may include up to 70 site visits.
Eligibility
Minimum age: 18 Years. 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).
Locations and Contacts
Amy Swartz, PT, MS, Phone: (617) 643-3980,
Email: fmurphy@partners.org
California Pacific Medical Center, San Francisco, California 94115, United States; Recruiting Dallas Foreshew, RN, BSN, Phone: 415-600-3938, Email: forshed@cpmcri.org
Jonathan Katz, MD, Principal Investigator Emory University, Atlanta, Georgia 30322, United States; Recruiting
Meraida Polak, RN, Phone: 404-778-3807, Email: mpolak@emory.edu Jonathan Glass, MD, Principal Investigator
University of Chicago, Chicago, Illinois 60637, United States; Recruiting Elizabeth Shaviers, Phone: 773-702-6221, Email: eshavier@neurology.bsd.uchicago.edu Kourosh Rezania, MD, Principal Investigator
Indiana University, Indianapolis, Indiana 46202, United States; Recruiting Sandy Guingrich, Phone: 317-630-6103, Email: sguingri@iupui.edu Robert Pascuzzi, MD, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting Darlene Pulley, Phone: 617-726-6190, Email: dpulley@partners.org Lisa Krivickas, 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
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
Wake Forest University, 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 Lien Ngo, Phone: 704-446-6253, Email: Lien.Ngo@carolinashealthcare.org Elena Bravver, MD, Principal Investigator
Methodist Neurological Institute, Houston, Texas 77030, United States; Recruiting Valrie Bickley, Phone: 713-441-5192, Email: vbickley@tmh.tmc.edu Ericka Simpson, MD, Principal Investigator
Additional Information
Northeast ALS Consortium website
Starting date: July 2006
Last updated: October 11, 2007
