A Trial of Tocilizumab in ALS Subjects

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Barrow Neurological Institute
Study ID
NCT02469896
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    IV Infusion
  • Placebo — OTHER
    IV Infusion

Study Details

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.

Key Dates

Start date
Nov 30, 2015
Status verified
Dec 2019
Primary completion
Jul 11, 2018
Completion
Jul 11, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    8 subjects will receive matching IV placebo every 4 weeks for 3 months.
  • Active Comparator: Active drug
    14 subjects will receive 8mg/kg of IV tocilizumab every 4 weeks for 3 months.

Primary Outcome Measure

Number of Patients Tolerant to Study Drug [ Time Frame: 16 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013-
University of Kansas Medical CenterKansas CityKansas66160-
Massachusetts General HospitalBostonMassachusetts02114-
Wake Forest University School of MedicineWinston-SalemNorth Carolina27157-
Penn State College of Medicine Milton S. Hershey Medical CenterHersheyPennsylvania17033-

Find similar trials in Phoenix, AZ

By research site
Barrow Neurological Institute· Phoenix, AZUniversity of Kansas Medical Center· Kansas City, KSMassachusetts General Hospital· Boston, MAWake Forest University School of Medicine· Winston-Salem, NCPenn State College of Medicine Milton S. Hershey Medical Center· Hershey, PA

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