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Clinical Trial Ceftriaxone in Subjects With ALS

NCT00349622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 513

Last updated 2014-04-21

Study results available
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Summary

The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).

Conditions

Interventions

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.

OTHER

placebo

an inactive substance

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Merit Cudkowicz, MD, MSc. · Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00349622 on ClinicalTrials.gov