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Status:

COMPLETED

Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

Lead Sponsor:

Emory University

Collaborating Sponsors:

ALS Association

Conditions:

Amyotrophic Lateral Sclerosis (ALS)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

In an ongoing safety trial of neural stem cell injections into the spinal cord of patients with ALS at Emory University, Atlanta, Georgia, one patient has demonstrated clear improvement by objective c...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for participants with symptom onset within the past 24 months:
  • Male or female patients 18-65 years of age.
  • ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial Criteria.
  • Symptom onset ≤ 24 months from screening visit.
  • A score of ≥38 on the Revised ALS Functional Rating Scale.
  • Slow vital capacity (SVC) measure \>80% of predicted for gender, height and age at screening.
  • Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to the screening visit (riluzole-naïve subjects are permitted in the study).
  • Negative tuberculosis (TB) test within 3 months of Screening Visit.
  • Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (i.e., no bleeding disorder, allergy to local anesthetics, or a skin infection at or near the LP site).
  • Capable of providing informed consent and following study procedures.
  • Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study.
  • Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.
  • Geographic accessibility to the study site.
  • Inclusion Criteria for participants with symptom onset greater than 24 months before screening:
  • Male or female patients age 18 or older.
  • ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial Criteria.
  • Symptom onset \>24 months from screening visit.
  • Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to the screening visit (riluzole-naïve subjects are permitted in the study).
  • Negative tuberculosis (TB) test within 3 months of Screening Visit.
  • Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (i.e., no bleeding disorder, allergy to local anesthetics, or a skin infection at or near the LP site).
  • Capable of providing informed consent and following study procedures.
  • Geographic accessibility to the study site.
  • Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study.
  • Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.
  • Exclusion Criteria
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2016

    Estimated Enrollment :

    31 Patients enrolled

    Trial Details

    Trial ID

    NCT01884571

    Start Date

    October 1 2013

    End Date

    January 1 2016

    Last Update

    November 6 2017

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Emory University

    Atlanta, Georgia, United States, 30322

    2

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    3

    University of Massachusetts Medical School

    Worcester, Massachusetts, United States, 01655