|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Massachusetts General Hospital National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00349622 |
Purpose
The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis ALS |
Drug: ceftriaxone Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Clinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Ceftriaxone
|
Drug: ceftriaxone
Participants will be randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. 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. |
| 2: Placebo Comparator |
Other: placebo
an inactive substance
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Texas | |
| Methodist Neurological Institute | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Merit Cudkowicz, MD, MSc. | Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital |
| Investigator: | Jeremy Shefner, MD, PhD | Professor of Neurology, State University of New York, Syracuse, Co-Investigator |
| Investigator: | Swati Aggarwal, MD | Neurologist, Co-Investigator |
More Information
| Responsible Party: | Harvard Medical School, Massachusetts General Hospital ( Merit E. Cudkowicz, MD, MSc, Associate Professor of Neurology ) |
| Study ID Numbers: | U01NS049640-02 |
| Study First Received: | July 5, 2006 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00349622 |
| Health Authority: | United States: Food and Drug Administration |
|
amyotrophic lateral sclerosis ALS ceftriaxone cephalosporin antibiotic motor neurons |
|
Cephalosporins Spinal Cord Diseases Central Nervous System Diseases Sclerosis Degenerative motor system disease Ceftriaxone Neurodegenerative Diseases |
Motor neuron disease Amyotrophic lateral sclerosis Neuromuscular Diseases Amyotrophic Lateral Sclerosis Cefixime Lou Gehrig's disease Motor Neuron Disease |
|
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes |
Therapeutic Uses Nervous System Diseases Pharmacologic Actions |
