Trial · NCT00349622

Clinical Trial Ceftriaxone in Subjects With ALS

NCT00349622, Phase 3, Completed, Massachusetts General Hospital; results first posted 2014-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial Ceftriaxone in Subjects With ALS. Trials, record NCT00349622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00349622

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial Ceftriaxone in Subjects With ALS
NCT number: NCT00349622
Status: Completed
Phases: Phase 3
Enrollment: 513 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Amyotrophic Lateral Sclerosis, ALS
Interventions: ceftriaxone, placebo
First posted: 2006-07-07
Last updated: 2014-04-21
Results first posted: 2014-04-01

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Survival	From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)	Survival is presented as median day of survival for each group. Survival is defined as time to death, tracheostomy or the initiation of permanent assisted ventilation (PAV).
Primary	Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year	Every 8 weeks for one year	Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised (ALSFRS-R) is a quickly administered (five minute) ordinal rating scale used to determine patients' assessment of their capability and independence in 12 functional activities/questions. The 12 functional activities/questions are rated on a scale of 0 to 4 for a total scoring range of 0-48, with 48 representing optimal function. All 12 activities are relevant in ALS. This outcome measure calculation is based on measurements every 8 weeks from the Baseline Visit up until one year.
Secondary	Change in % Vital Capacity From Screening to One Year	Every 12 weeks for one Year	Vital Capacity is measured as the percent predicted per subject based on age, gender, and height, and is performed as a Slow Vital Capacity. This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year.
Secondary	Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year	Every 12 weeks for one Year	Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally. HHD analysis was performed using Percent Change from Baseline. Each subject's baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles. This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year.
Secondary	Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year	Every 12 weeks for one Year	The ALS-Specific Quality of Life Scale (ALSQOL). was developed, tested, and validated in subjects with ALS, and is not a health-related quality of life scale. The scale consists of 59 questions that ask about severity of the symptoms of ALS, mood and affect, intimacy, and social issues. Each question for the ALSQOL is scored from 0-10. With 59 questions, total score ranges from 0-590 with scores simply added, with 590 representing highest quality of life. However since 10 is maximally weighted towards negative values on some questions and positive values on others, the following questions must have results transposed (Simply reverse the scale, for instance 10=0 and 0=10) prior to analysis: 1-10, 11, 16, 19, 24, 26, 28, 32, 35, 36, 38, and 41. Optional items are 50, 53, 56, and 59. These questions are not included on any scale or in any quantitative analyses. This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year.
Secondary	Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year	Every 12 weeks for one Year	Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally. HHD analysis was performed using Percent Change from Baseline. Each subject's baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles. This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Survival	From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)	days	MEDIAN
PRIMARY	Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year	Every 8 weeks for one year	units on a scale per 8 weeks	MEAN
SECONDARY	Change in % Vital Capacity From Screening to One Year	Every 12 weeks for one Year	percent change in VC per 12 weeks	MEAN
SECONDARY	Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year	Every 12 weeks for one Year	Percent change per 12 weeks	MEAN
SECONDARY	Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year	Every 12 weeks for one Year	units on a scale per 12 weeks	MEAN
SECONDARY	Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year	Every 12 weeks for one Year	Percent change per 12 weeks	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Survival	Ceftriaxone	664	95% Confidence Interval 614 to 794	days
Survival	Placebo	581	95% Confidence Interval 521 to 672	days
Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year	Ceftriaxone	-1.1311	Standard Error 0.04395	units on a scale per 8 weeks
Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year	Placebo	-1.2208	Standard Error 0.06177	units on a scale per 8 weeks
Change in % Vital Capacity From Screening to One Year	Ceftriaxone	-2.772	Standard Error 0.1417	percent change in VC per 12 weeks
Change in % Vital Capacity From Screening to One Year	Placebo	-3.0826	Standard Error 0.1970	percent change in VC per 12 weeks
Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year	Ceftriaxone	-5.2735	Standard Error 0.2178	Percent change per 12 weeks
Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year	Placebo	-5.5526	Standard Error 0.3040	Percent change per 12 weeks
Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year	Ceftriaxone	-3.5084	Standard Error 0.3297	units on a scale per 12 weeks
Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year	Placebo	-3.4401	Standard Error 0.4629	units on a scale per 12 weeks

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ceftriaxone	340
Overall Study	STARTED	Placebo	173
Overall Study	COMPLETED	Ceftriaxone	162
Overall Study	COMPLETED	Placebo	77
Overall Study	NOT COMPLETED	Ceftriaxone	178
Overall Study	NOT COMPLETED	Placebo	96

Source ClinicalTrials.gov

Adverse events304

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Ceftriaxone	152	340	220
other	Diarrhea	Gastrointestinal disorders	Placebo	41	173	51
other	Cholelithiasis	Hepatobiliary disorders	Ceftriaxone	158	340	193
other	Cholelithiasis	Hepatobiliary disorders	Placebo	5	173	5
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Ceftriaxone	32	340	38
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	24	173	26
other	Neurology - Other	Nervous system disorders	Ceftriaxone	97	340	183
other	Neurology - Other	Nervous system disorders	Placebo	52	173	92
other	Catheter Exit Site Reaction	General disorders	Ceftriaxone	98	340	143
other	Catheter Exit Site Reaction	General disorders	Placebo	45	173	69

1 to 10 of 304Source ClinicalTrials.gov

See all 304 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ceftriaxone
Total, all-cause mortality	Placebo
Total, other adverse events	Ceftriaxone	331	340
Total, other adverse events	Placebo	153	173
Total, serious adverse events	Ceftriaxone	276	340
Total, serious adverse events	Placebo	125	173

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23613806	DERIVED	PubMed
25297012	DERIVED	PubMed
28864675	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01NS049640	Clinical Trial of Ceftriaxone in Subjects with ALS	CUDKOWICZ, MERIT E	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2006 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ceftriaxone vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00349622

GET https://conductscience.org/api/trials/v1/NCT00349622/events?page=2

API reference For AI assistants