Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

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.

Trial Locations (3)

30322

Emory University, Atlanta

02114

Massachusetts General Hospital, Boston

01655

University of Massachusetts Medical School, Worcester

All Listed Sponsors
collaborator

ALS Association

OTHER

lead

Emory University

OTHER

NCT01884571 - Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) | Biotech Hunter | Biotech Hunter