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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Massachusetts General Hospital |
| 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: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (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. Two thirds of participants will receive ceftriaxone and one third will receive placebo. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving. 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 (2/3 of participants) or placebo (1/3 of participants) for at least 12 months.
The study consists of three stages. The first stage, which has completed enrollment, will look at whether ceftriaxone enters the cerebrospinal fluid (the fluid that surrounds the spinal cord, also called CSF) in amounts that are high enough to be of possible benefit. The second stage, which has also completed enrollment, will look at the safety and side effects of the study drug when taken daily for at least 20 weeks. The third stage, which will begin enrollment in Spring 2009, will determine whether the study drug prolong survival and slows decline in function due to ALS.
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| Contact: Amy Swartz, PT, DPT | (617) 643-3980 | fmurphy@partners.org |
| Contact: Katie Delaney | (617) 643-3980 | fmurphy@partners.org |
Show 55 Study Locations| Principal Investigator: | Merit Cudkowicz, MD, MSc. | Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital |
More Information
| Responsible Party: | Harvard Medical School, Massachusetts General Hospital ( Merit E. Cudkowicz, MD, MSc, Associate Professor of Neurology ) |
| Study ID Numbers: | U01NS049640-02, NINDS, U01NS049640-02, NINDS CRC |
| Study First Received: | July 5, 2006 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00349622 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
amyotrophic lateral sclerosis ALS ceftriaxone cephalosporin antibiotic motor neurons |
|
Ceftriaxone Amyotrophic Lateral Sclerosis Anti-Infective Agents Spinal Cord Diseases Nervous System Diseases Central Nervous System Diseases Sclerosis |
Neurodegenerative Diseases Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Neuromuscular Diseases Therapeutic Uses Motor Neuron Disease |
