Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

This is a multicenter, 15-month study evaluating the effect of immunosuppression treatment on the rate of change on the ALS Functional Rating Scale (Revised) (ALSFRS-R) score in up to 33 subjects with Amyotrophic Lateral Sclerosis (ALS).

Key facts

Study ID

NCT01884571

Run by

Emory University

People needed

31

Starts

2013-10-01

Expected to finish

2016-01-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior use of basiliximab, solumedrol, prednisone, tacrolimus or mycophenolate mofetil within 30 days of the Screening Visit.
• Known allergy or sensitivity to basiliximab, solumedrol, prednisone, tacrolimus or mycophenolate mofetil or a formulation of one of these drugs.
• Treatment with an immunosuppressant medication within 30 days of the Screening Visit.
• Active peptic ulcer disease.
• Any medical disorder that would make immunosuppression contraindicated including, but not limited to, human immunodeficiency virus (HIV), tuberculosis, or evidence of active cytomegalovirus (CMV) or infection.
• Subjects who have a diaphragm pacing system (DPS).
• Women who are pregnant, breastfeeding, or planning to become pregnant in the next 12 months.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Use of invasive or non-invasive mechanical ventilation (including Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP)) for any part of the day or night prior to the Screening Visit (participants with symptom onset within past 24 months only).
• Exposure to any other agent currently under investigation for the treatment of patients with ALS (off-label use or investigational) within 30 days of the Screening Visit.
• Inability to safely complete study activities based on the discretion of the site investigator.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.