At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 513 enrolled

Drug / intervention

ceftriaxone +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00349622

NCT00349622Phase 3Completed

Compare CT.gov

Clinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Massachusetts General Hospital·interventional·Posted Jul 7, 2006·Updated Apr 21, 2014

In Brief

A Phase 3 clinical trial evaluating ceftriaxone and placebo for Amyotrophic Lateral Sclerosis and ALS. Completed, enrolled 513 participants across 58 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAmyotrophic Lateral Sclerosis, ALS

CountriesCanada, United States

CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2006

First PostedJul 2006

Primary CompletionNov 2012

TodayJul 2026

First PostedJul 7, 2006

Enrollment StartJul 1, 2006

Primary CompletionNov 1, 2012

TodayJul 2, 2026

Enrollment to primary: 6.3 yearsPosted 20.0 years ago

Interventions

ceftriaxonedrug

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.

placeboother

an inactive substance