A Trial of Tocilizumab in ALS Subjects (TCZALS-001)
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ClinicalTrials.gov Identifier: NCT02469896 |
Recruitment Status :
Completed
First Posted : June 12, 2015
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
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Sponsor:
Barrow Neurological Institute
Collaborators:
ALS Association
Barrow Neurological Foundation
Massachusetts General Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Shafeeq Ladha, MD, Barrow Neurological Institute
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
ALS Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Motor Neuron Disease |
Interventions |
Drug: Tocilizumab Other: Placebo |
Enrollment | 22 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | Active Drug |
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8 subjects will receive matching IV placebo every 4 weeks for 3 months. Placebo: IV Infusion |
16 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months. Tocilizumab: IV Infusion |
Period Title: Overall Study | ||
Started | 8 | 14 |
Completed | 6 | 14 |
Not Completed | 2 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | Active Drug | Total | |
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8 subjects will receive matching IV placebo every 4 weeks for 3 months. Placebo: IV Infusion |
16 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months. Tocilizumab: IV Infusion |
Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 14 | 22 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 8 participants | 14 participants | 22 participants | |
59.2 (8.6) | 61.9 (8.7) | 60.9 (8.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 14 participants | 22 participants | |
Female |
3 37.5%
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3 21.4%
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6 27.3%
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Male |
5 62.5%
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11 78.6%
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16 72.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 14 participants | 22 participants | |
Hispanic or Latino |
1 12.5%
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0 0.0%
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1 4.5%
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Not Hispanic or Latino |
7 87.5%
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14 100.0%
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21 95.5%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 14 participants | 22 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 12.5%
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0 0.0%
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1 4.5%
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White |
7 87.5%
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14 100.0%
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21 95.5%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 8 participants | 14 participants | 22 participants |
8 100.0%
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14 100.0%
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22 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Shafeeq Ladha, MD |
Organization: | Barrow Neurological Institute |
Phone: | 602-406-8989 |
EMail: | Shafeeq.Ladha@Barrowneuro.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shafeeq Ladha, MD, Barrow Neurological Institute |
ClinicalTrials.gov Identifier: | NCT02469896 |
Other Study ID Numbers: |
2015TCZALS-001 |
First Submitted: | June 3, 2015 |
First Posted: | June 12, 2015 |
Results First Submitted: | August 6, 2019 |
Results First Posted: | December 18, 2019 |
Last Update Posted: | December 18, 2019 |