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Trial record 3 of 7 for:    feinberg school of medicine OR northwestern university medical school | ALS

Clinical Trial Ceftriaxone in Subjects With ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00349622
Recruitment Status : Completed
First Posted : July 7, 2006
Results First Posted : April 1, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Merit E. Cudkowicz, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Amyotrophic Lateral Sclerosis
ALS
Interventions Drug: ceftriaxone
Other: placebo
Enrollment 513

Recruitment Details Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Subjects with ALS were enrolled in 58 institutions across in the US and Canada.
Pre-assignment Details Participants were randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants received ceftriaxone and one third received placebo. This is a blinded study, so neither participants nor study staff knew which treatment a participant is receiving.
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Period Title: Overall Study
Started 340 173
Completed 162 77
Not Completed 178 96
Reason Not Completed
Death             168             86
Lost to Follow-up             5             1
Withdrawal by Subject             5             9
Arm/Group Title Ceftriaxone Placebo Total
Hide Arm/Group Description

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Total of all reporting groups
Overall Number of Baseline Participants 340 173 513
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age at Screening Number Analyzed 340 participants 173 participants 513 participants
55.6  (10.4) 54.8  (10.3) 55.4  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
Female
131
  38.5%
72
  41.6%
203
  39.6%
Male
209
  61.5%
101
  58.4%
310
  60.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
Hispanic or Latino
17
   5.0%
6
   3.5%
23
   4.5%
Not Hispanic or Latino
320
  94.1%
165
  95.4%
485
  94.5%
Unknown or Not Reported
3
   0.9%
2
   1.2%
5
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
American Indian or Alaska Native
2
   0.6%
0
   0.0%
2
   0.4%
Asian
6
   1.8%
5
   2.9%
11
   2.1%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
Black or African American
8
   2.4%
3
   1.7%
11
   2.1%
White
320
  94.1%
163
  94.2%
483
  94.2%
More than one race
2
   0.6%
0
   0.0%
2
   0.4%
Unknown or Not Reported
1
   0.3%
2
   1.2%
3
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
United States 293 151 444
Canada 47 22 69
ALS Family History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
Familial History of ALS 26 8 34
No Known Familial History of ALS 307 161 468
Unknown 7 4 11
[1]
Measure Description: Subjects were asked at screening whether or not they have a familial history of ALS.
Site of Onset   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
Limb 257 137 394
Bulbar 75 35 110
Both 8 1 9
[1]
Measure Description: Indicates region of first symptoms
Riluzole Use   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants 173 participants 513 participants
On Riluzole 249 128 377
Not on Riluzole 91 45 136
[1]
Measure Description: At the screening visit, subjects were asked whether or not they were taking a continuous dose of riluzole.
Vital Capacity Percent Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted based on age and heigh
Number Analyzed 340 participants 173 participants 513 participants
87.9  (16.6) 91.1  (18.4) 89.0  (17.3)
[1]
Measure Description: The vital capacity (lung capacity) for each subject was measured at screening.
Time to Screening  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 340 participants 173 participants 513 participants
Years from Symptom Onset to Screening 1.49  (0.68) 1.50  (0.67) 1.49  (0.68)
Years from Diagnosis to Screening 0.56  (0.49) 0.58  (0.49) 0.57  (0.49)
Years from Symptom Onset to Diagnosis 0.93  (0.55) 0.92  (0.58) 0.92  (0.56)
1.Primary Outcome
Title Survival
Hide Description 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).
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description:

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Overall Number of Participants Analyzed 340 173
Median (95% Confidence Interval)
Unit of Measure: days
664
(614 to 794)
581
(521 to 672)
2.Primary Outcome
Title Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year
Hide Description

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.

Time Frame Every 8 weeks for one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description:

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Overall Number of Participants Analyzed 340 173
Mean (Standard Error)
Unit of Measure: units on a scale per 8 weeks
-1.1311  (0.04395) -1.2208  (0.06177)
3.Secondary Outcome
Title Change in % Vital Capacity From Screening to One Year
Hide Description

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.

Time Frame Every 12 weeks for one Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description:

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Overall Number of Participants Analyzed 340 173
Mean (Standard Error)
Unit of Measure: percent change in VC per 12 weeks
-2.772  (0.1417) -3.0826  (0.1970)
4.Secondary Outcome
Title Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year
Hide Description

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.

Time Frame Every 12 weeks for one Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description:

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Overall Number of Participants Analyzed 340 173
Mean (Standard Error)
Unit of Measure: Percent change per 12 weeks
-5.2735  (0.2178) -5.5526  (0.3040)
5.Secondary Outcome
Title Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year
Hide Description

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.

Time Frame Every 12 weeks for one Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description:

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Overall Number of Participants Analyzed 340 173
Mean (Standard Error)
Unit of Measure: units on a scale per 12 weeks
-3.5084  (0.3297) -3.4401  (0.4629)
6.Secondary Outcome
Title Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year
Hide Description

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.

Time Frame Every 12 weeks for one Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description:

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

Overall Number of Participants Analyzed 340 173
Mean (Standard Error)
Unit of Measure: Percent change per 12 weeks
-4.1530  (0.2591) -4.4807  (0.3625)
Time Frame Adverse Events were systematically assessed by study investigators at each study visit from the screening visit until 30 days after permanent study drug discontinuation. The total amount of time per subject varies by length of subject participation.
Adverse Event Reporting Description Adverse Events were systematically assessed by study investigators at each study visit from the screening visit until 30 days after permanent study drug discontinuation.
 
Arm/Group Title Ceftriaxone Placebo
Hide Arm/Group Description

Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.

One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.

Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.

All-Cause Mortality
Ceftriaxone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ceftriaxone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   276/340 (81.18%)      125/173 (72.25%)    
Blood and lymphatic system disorders     
Blood/Bone Marrow - Other  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Febrile neutropenia (fever of unknown origin w/out clinically/microbiologically documented infection  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Cardiac disorders     
Cardiac ischemia/infarction  1  6/340 (1.76%)  8 0/173 (0.00%)  0
Cardiac/Arrhythmia Other  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Left ventricular diastolic dysfunction  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Supraventricular and nodal arrhythmias: Sinus bradycardia  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Ventricular arrhythmia: Ventricular tachycardia  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Gastrointestinal disorders     
Dysphagia  1  4/340 (1.18%)  4 2/173 (1.16%)  2
Pain: Abdomen NOS  1  3/340 (0.88%)  3 1/173 (0.58%)  1
Constipation  1  1/340 (0.29%)  1 2/173 (1.16%)  2
Diarrhea  1  3/340 (0.88%)  3 0/173 (0.00%)  0
Gastrointestinal - Other  1  0/340 (0.00%)  0 3/173 (1.73%)  3
Colitis  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Gastritis (including bile reflux gastritis)  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Heartburn/Dyspepsia  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Hemmorhage, GI: Lower GI NOS  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Hemmorhage, GI: Stomach  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Obstruction, GI: Ileum  1  1/340 (0.29%)  2 0/173 (0.00%)  0
Obstruction, GI: Stomach  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Pain: Stomach  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Vomiting  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Pancreatitis  1  7/340 (2.06%)  7 0/173 (0.00%)  0
General disorders     
Death not associated with CTCAE Term: Disease Progression NOS  1  4/340 (1.18%)  4 4/173 (2.31%)  4
Death not associated with CTCAE term: Death NOS  1  3/340 (0.88%)  3 1/173 (0.58%)  1
Fever (in the absense of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)  1  2/340 (0.59%)  2 2/173 (1.16%)  2
Death not associated with CTCAE Term: Sudden Death  1  2/340 (0.59%)  2 0/173 (0.00%)  0
Line break/tear  2 [1]  2/340 (0.59%)  2 0/173 (0.00%)  0
Line Displacement  2 [2]  1/340 (0.29%)  1 1/173 (0.58%)  1
Line Thrombosis  2 [3]  1/340 (0.29%)  1 0/173 (0.00%)  0
Pain: Chest/thorax NOS  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis  1  28/340 (8.24%)  30 0/173 (0.00%)  0
Cholecystitis  1  5/340 (1.47%)  5 0/173 (0.00%)  0
Biliary Sludge  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Hepatobiliary - Other  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  4/340 (1.18%)  4 0/173 (0.00%)  0
Infections and infestations     
Infections with unknown ANC: Lung (pneumonia)  1  13/340 (3.82%)  17 12/173 (6.94%)  14
Line Infection  2 [4]  3/340 (0.88%)  4 9/173 (5.20%)  11
Infection with normal ANC or grade 1 or 2 neutrophils: Lung (pneumonia)  1  4/340 (1.18%)  4 2/173 (1.16%)  2
Catheter Exit Site Infection  2 [5]  2/340 (0.59%)  2 3/173 (1.73%)  3
Infection with normal ANC or grade 1 or 2 neutrophils: Blood  1  1/340 (0.29%)  1 3/173 (1.73%)  3
Infections with unknown ANC: Blood  1  1/340 (0.29%)  1 3/173 (1.73%)  3
Colitis infectious (Clostridium difficile)  1  3/340 (0.88%)  3 0/173 (0.00%)  0
Infection with unknown ANC: Urinary tract NOS  1  0/340 (0.00%)  0 3/173 (1.73%)  3
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia: Lung  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Infection - Other  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Infection with normal ANC or grade 1 or 2 neutrophils: Bronchus  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Infection with normal ANC or grade 1 or 2 neutrophils: Vagina  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Infection with unknown ANC: Abdomen NOS  1  1/340 (0.29%)  2 0/173 (0.00%)  0
Infection with unknown ANC: Catheter-related  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Infection with unknown ANC: Foreign body (e.g. graft, implant, prosthesis, stent)  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Infection with unknown ANC: Soft tissue NOS  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Injury, poisoning and procedural complications     
Fracture  1  3/340 (0.88%)  3 3/173 (1.73%)  3
Hemmorhage, pulmonary/Upper Respiratory: Stoma  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Hemorrhage/bleeding associated with surgery, intraoperative or postoperative  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Leak (including anastomotic), GI: Stomach  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Investigations     
FEV (1)  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Metabolic/Laboratory - Other  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Weight loss  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Metabolism and nutrition disorders     
Dehydration  1  2/340 (0.59%)  2 0/173 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint-function  1  2/340 (0.59%)  2 1/173 (0.58%)  1
Musculoskeletal - Other  1  2/340 (0.59%)  2 0/173 (0.00%)  0
Pain: chest wall  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Nervous system disorders     
CNS cerebrovascular ischemia  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Neurology - Other  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Somnolence/depressed level of consciousness  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Cognitive disturbance  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Hemmorhage, CNS  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Pain: Head/headache  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Psychiatric disorders     
Mood alteration: Depression  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Confusion  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Mood alteration: Agitation  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Mood alteration: Anxiety  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Renal and urinary disorders     
Renal/Genitourinary - Other  1  10/340 (2.94%)  10 1/173 (0.58%)  1
Renal failure  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Stricture/stenosis (including anastomotic), GU: Ureter  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Urinary retention (including nerogenic bladder)  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Reproductive system and breast disorders     
Sexual/Reproductive Function - Other  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  74/340 (21.76%)  79 34/173 (19.65%)  35
Aspiration  1  6/340 (1.76%)  6 2/173 (1.16%)  2
Pulmonary - Other  1  4/340 (1.18%)  5 0/173 (0.00%)  0
Hypoxia  1  2/340 (0.59%)  2 0/173 (0.00%)  0
Obstruction/stenosis of airway: Larynx  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Pneumonitis/pulmonary infiltrates  1  1/340 (0.29%)  1 1/173 (0.58%)  1
Pneumothorax  1  2/340 (0.59%)  2 0/173 (0.00%)  0
Atelectasis  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Cough  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Obstruction/stenosis of airway: Trachea  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other  1  1/340 (0.29%)  1 0/173 (0.00%)  0
Surgical and medical procedures     
PEG Placement (outpatient)  2 [6]  4/340 (1.18%)  4 5/173 (2.89%)  6
Vascular disorders     
Thrombosis/thrombus/embolism  1  20/340 (5.88%)  20 4/173 (2.31%)  4
Hematoma  1  2/340 (0.59%)  2 0/173 (0.00%)  0
Hypotension  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Thrombosis/embolism (vascular access-related)  1  0/340 (0.00%)  0 1/173 (0.58%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (3.0) suppl.
[1]
"Line break/tear" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
[2]
"Line Displacement" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
[3]
"Line Thrombosis" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
[4]
"Line Infection" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
[5]
"Catheter Exit Site Infection" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
[6]
PEG (Percutaneous Endoscopic Gastrostomy) Placement was added as an adverse event term during STAGES 1 and 2 of this study. PEG tube placements are common for people with ALS. In STAGE 3 of the study, these events were coded as Dysphagia.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ceftriaxone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   331/340 (97.35%)      153/173 (88.44%)    
Blood and lymphatic system disorders     
Lymphopenia  1  20/340 (5.88%)  24 4/173 (2.31%)  6
Gastrointestinal disorders     
Diarrhea  1  152/340 (44.71%)  220 41/173 (23.70%)  51
Constipation  1  66/340 (19.41%)  76 30/173 (17.34%)  34
Nausea  1  64/340 (18.82%)  115 28/173 (16.18%)  39
Dysphagia, (difficult swallowing)  1  35/340 (10.29%)  38 17/173 (9.83%)  17
Gastrointestinal - Other  1  36/340 (10.59%)  41 12/173 (6.94%)  16
Heartburn/Dyspepsia  1  24/340 (7.06%)  26 12/173 (6.94%)  14
Vomiting  1  24/340 (7.06%)  33 10/173 (5.78%)  13
General disorders     
Catheter Exit Site Reaction  2 [1]  98/340 (28.82%)  143 45/173 (26.01%)  69
Pain: Abdomen NOS  1  75/340 (22.06%)  114 16/173 (9.25%)  17
Edema: Limb  1  54/340 (15.88%)  68 22/173 (12.72%)  25
Fatigue (asthenia, lethargy, malaise)  1  41/340 (12.06%)  44 24/173 (13.87%)  26
Pain: Neck  1  34/340 (10.00%)  37 15/173 (8.67%)  17
Fever (absence of neutropenia, where neutropenia is AGC <1.0x10e9/L)  1  27/340 (7.94%)  28 12/173 (6.94%)  15
Line break/tear  1 [2]  19/340 (5.59%)  21 11/173 (6.36%)  12
Pain - Other  1  18/340 (5.29%)  26 12/173 (6.94%)  13
Hepatobiliary disorders     
Cholelithiasis  1  158/340 (46.47%)  193 5/173 (2.89%)  5
Biliary Sludge  1  100/340 (29.41%)  110 12/173 (6.94%)  12
Hepatobiliary - Other  1  20/340 (5.88%)  25 5/173 (2.89%)  6
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  19/340 (5.59%)  25 7/173 (4.05%)  7
Infections and infestations     
Infection - Other  1  42/340 (12.35%)  64 15/173 (8.67%)  18
Infection with normal ANC or grade 1 or 2 neutrophils: Urinary Tract NOS  1  25/340 (7.35%)  29 17/173 (9.83%)  24
Infection with unknown ANC: Upper airway NOS  1  20/340 (5.88%)  34 9/173 (5.20%)  10
Infection with unkown ANC: Urinary tract NOS  1  17/340 (5.00%)  18 11/173 (6.36%)  15
Injury, poisoning and procedural complications     
Bruising (in absence of grade 3 or 4 thrombocytopenia)  1  24/340 (7.06%)  44 10/173 (5.78%)  15
Fracture  1  24/340 (7.06%)  29 10/173 (5.78%)  11
Investigations     
ALT SGPT (serum glutamic pyruvic transaminase)  1  32/340 (9.41%)  42 5/173 (2.89%)  6
Neutrophils/granulocytes (ANC/AGC)  1  30/340 (8.82%)  41 2/173 (1.16%)  2
Metabolic/Laboratory  1  18/340 (5.29%)  22 13/173 (7.51%)  20
AST SGOT (serum glutamic oxaloacetic transaminase)  1  23/340 (6.76%)  27 4/173 (2.31%)  5
Weight loss  1  15/340 (4.41%)  16 11/173 (6.36%)  11
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower  1  46/340 (13.53%)  61 26/173 (15.03%)  30
Pain: Back  1  53/340 (15.59%)  59 17/173 (9.83%)  22
Pain: Joint  1  47/340 (13.82%)  62 19/173 (10.98%)  24
Musculoskeletal - Other  1  45/340 (13.24%)  57 17/173 (9.83%)  24
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper  1  39/340 (11.47%)  48 19/173 (10.98%)  22
Pain: Extremity-limb  1  38/340 (11.18%)  53 10/173 (5.78%)  12
Pain: chest wall  1  25/340 (7.35%)  29 12/173 (6.94%)  17
Muscle weakness, generalized of specific area (not due to neuropathy): Whole body/generalized  1  27/340 (7.94%)  29 8/173 (4.62%)  9
Nervous system disorders     
Neurology - Other  1  97/340 (28.53%)  183 52/173 (30.06%)  92
Pain: head/headache  1  53/340 (15.59%)  79 32/173 (18.50%)  37
Drooling  1  30/340 (8.82%)  30 16/173 (9.25%)  16
Dizziness  1  25/340 (7.35%)  32 15/173 (8.67%)  18
Voice changes/dysarthria (e.g., hoarseness, loss or alteration of voice, laryngitis)  1  25/340 (7.35%)  27 11/173 (6.36%)  11
Psychiatric disorders     
Insomnia  1  40/340 (11.76%)  42 19/173 (10.98%)  19
Mood alteration: Depression  1  33/340 (9.71%)  33 21/173 (12.14%)  21
Mood alteration: Anxiety  1  34/340 (10.00%)  38 14/173 (8.09%)  14
Renal and urinary disorders     
Renal/Genitourinary - Other  1  37/340 (10.88%)  57 13/173 (7.51%)  20
Urinary frquency/urgency  1  20/340 (5.88%)  21 11/173 (6.36%)  13
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  32/340 (9.41%)  38 24/173 (13.87%)  26
Pulmonary - Other  1  46/340 (13.53%)  57 20/173 (11.56%)  25
Cough  1  41/340 (12.06%)  48 12/173 (6.94%)  15
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  23/340 (6.76%)  25 14/173 (8.09%)  16
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  92/340 (27.06%)  122 29/173 (16.76%)  36
Dermatology/Skin - Other  1  57/340 (16.76%)  78 21/173 (12.14%)  25
Pruritis/itching  1  33/340 (9.71%)  41 14/173 (8.09%)  14
Vascular disorders     
Hypertension  1  16/340 (4.71%)  22 9/173 (5.20%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (3.0) suppl.
[1]
"Catheter Exit Site Reaction" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
[2]
"Line break/tear" was added to the trial database as an adverse event potentially related to the central venous catheter that all subjects received as part of the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Merit Cudkowicz
Organization: MGH
Phone: 617-724-1873
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merit E. Cudkowicz, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00349622     History of Changes
Other Study ID Numbers: U01NS049640-02 ( U.S. NIH Grant/Contract )
NINDS ( Other Identifier: NINDS )
U01NS049640-02 ( U.S. NIH Grant/Contract )
NINDS CRC ( Other Identifier: NINDS Clinical Research Collaboration )
First Submitted: July 5, 2006
First Posted: July 7, 2006
Results First Submitted: October 23, 2013
Results First Posted: April 1, 2014
Last Update Posted: April 21, 2014