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Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

NCT01884571 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-11-06

Study results available
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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 Amyotrophic Lateral Sclerosis (ALS).

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Basiliximab

20 mg, IV (in the vein) on day 1 and 4.

DRUG

Methylprednisolone

125 mg, IV (in the vein) on day 1.

DRUG

Prednisone

60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.

DRUG

Tacrolimus

1-5 mg PO, twice a day (BID) days 2-180.

DRUG

Mycophenolate mofetil

500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180.

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Jonathan D Glass, MD · Emory University

  • Christina N Fournier, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-01-31
Completion
2016-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01884571 on ClinicalTrials.gov