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Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone

NCT00947895 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-03-22

No results posted yet for this study

Summary

The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.

Conditions

Interventions

DRUG

Methylprednisolone

IV 1000 mg daily for 3 days

DRUG

ACTH

IM ACTH 80 mg/day for 5 days.

OTHER

IV placebo

IV placebo (saline) daily for 3 days.

OTHER

IM placebo

IM placebo (saline) daily for 5 days.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Neurologique Foundation, Inc.

    lead OTHER

Principal Investigators

  • Daniel Kantor, MD · Neurologique Foundation, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00947895 on ClinicalTrials.gov