Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) (NIPALS2013)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01884571 |
Recruitment Status :
Completed
First Posted : June 24, 2013
Results First Posted : July 31, 2017
Last Update Posted : November 6, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Amyotrophic Lateral Sclerosis (ALS) |
Interventions |
Drug: Basiliximab Drug: Methylprednisolone Drug: Prednisone Drug: Tacrolimus Drug: Mycophenolate mofetil |
Enrollment | 31 |
Recruitment Details | Participants were recruited for this study from three Northeast ALS Consortium (NEALS) centers in the USA (Emory University in Atlanta, Georgia, Massachusetts General Hospital in Boston, Massachusetts, and University of Massachusetts Medical School in Worcester, Massachusetts. Recruitment occurred between October 2013 and October 2014. |
Pre-assignment Details |
Arm/Group Title | Immunosuppression Regimen |
---|---|
![]() |
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment (described below) and the treatment period lasted for six months. Basiliximab: 20 mg, IV (in the vein) on day 1 and 4. Methylprednisolone: 125 mg, IV (in the vein) on day 1. 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. Tacrolimus: 1-5 mg PO, twice a day (BID) days 2-180. 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. |
Period Title: Overall Study | |
Started | 31 |
Completed | 23 |
Not Completed | 8 |
Reason Not Completed | |
Adverse Event | 1 |
Death | 2 |
Withdrawal by Subject | 2 |
Disease progression | 3 |
Arm/Group Title | Immunosuppression Regimen | |
---|---|---|
![]() |
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months. | |
Overall Number of Baseline Participants | 31 | |
![]() |
[Not Specified]
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
Number Analyzed | 31 participants | |
53.9 (11.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 31 participants | |
Female |
6 19.4%
|
|
Male |
25 80.6%
|
|
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
||
United States | Number Analyzed | 31 participants |
31 100.0%
|
||
Timing of Symptom Onset
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 31 participants |
Less than or equal to 24 months prior to screening |
20 64.5%
|
|
More than 24 months prior to screening |
11 35.5%
|
Name/Title: | Jonathan Glass, MD |
Organization: | Emory University |
Phone: | 404-727-3507 |
EMail: | jglas03@emory.edu |
Responsible Party: | Jonathan D. Glass, M.D., Emory University |
ClinicalTrials.gov Identifier: | NCT01884571 |
Other Study ID Numbers: |
IRB00064218 NIP-ALS-2013 ( Other Identifier: Other ) 2013P000981 ( Other Identifier: Other ) |
First Submitted: | June 19, 2013 |
First Posted: | June 24, 2013 |
Results First Submitted: | May 12, 2017 |
Results First Posted: | July 31, 2017 |
Last Update Posted: | November 6, 2017 |