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A Trial of Tocilizumab in ALS Subjects

NCT02469896 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-12-18

Study results available
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Summary

This research study is being done to find out if tocilizumab, also known as Actemra™, can help with Amyotrophic Lateral Sclerosis (ALS). The investigators also want to find out if tocilizumab is safe to take without causing too many side effects.

Currently ALS has no cure and 2 modestly effective treatment to slow the progression of the disease. Although not the initial cause of ALS, the immune system plays a role in the death of motor neurons. The immune cells that participate in this process are stimulated by a substance called interleukin-6 (IL-6) whose effect is blocked by tocilizumab and thus, may slow the death of motor neurons and slow the disease.

Conditions

Interventions

DRUG

Tocilizumab

IV Infusion

OTHER

Placebo

IV Infusion

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER

  • Barrow Neurological Foundation

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Barrow Neurological Institute

    lead OTHER

Principal Investigators

  • Shafeeq Ladha, MD · Barrow Neurological Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-07-11
Completion
2018-07-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469896 on ClinicalTrials.gov