At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 31 enrolled

Drug / intervention

Basiliximab +4 moredrug

Likely dose

Basiliximab 20 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01884571

NCT01884571Phase 2Completed

Compare CT.gov

A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Emory University·interventional·Posted Jun 24, 2013·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating Basiliximab, Methylprednisolone, and 3 other interventions for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 31 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAmyotrophic Lateral Sclerosis (ALS)

CountriesUnited States

CollaboratorsALS Association

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedJun 2013

Enrollment StartOct 2013

Primary CompletionJan 2016

TodayJul 2026

First PostedJun 24, 2013

Enrollment StartOct 1, 2013

Primary CompletionJan 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 13.0 years ago

Interventions

Basiliximabdrug

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

Methylprednisolonedrug

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

Prednisonedrug

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.

Tacrolimusdrug

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

Mycophenolate mofetildrug

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.