Phase 3
Completed N=513
Clinical Trial Ceftriaxone in Subjects With ALS
Source: ClinicalTrials.gov NCT00349622 ↗Enrolled (actual)
513
Serious AEs
78.2%
Results posted
Apr 2014
Primary outcomePrimary: Survival — 664; 581 days
Summary
The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
664; 581 | — |
| PRIMARY Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year |
-1.1311; -1.2208 | — |
| SECONDARY Change in % Vital Capacity From Screening to One Year |
-2.772; -3.0826 | — |
| SECONDARY Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year |
-5.2735; -5.5526 | — |
| SECONDARY Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year |
-3.5084; -3.4401 | — |
| SECONDARY Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year |
-4.1530; -4.4807 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT00349622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.