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Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis

NCT02296346 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-08-14

Study results available
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Summary

In this research study, the investigators will determine whether a procedure called Extracorporeal Photopheresis (ECP) is helpful in preventing progression of disability in people with SPMS when compared to monthly corticosteroid infusions. This study will determine whether ECP has an effect on inflammatory cells in people with SPMS and whether it has a beneficial therapeutic effect.

Conditions

  • Secondary Progressive Multiple Sclerosis

Interventions

DRUG

SoluMedrol

Infusion of drug subcutaneously, once a month.

DEVICE

Extracorporeal Photopheresis

This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body.

Sponsors & Collaborators

Principal Investigators

  • Benjamin Segal, MD · University of Michigan, Director of Multiple Sclerosis Center

  • Daniel Couriel, MD · University of Utah, Huntsman Cancer Institute, Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-06-13
Completion
2018-05-10

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02296346 on ClinicalTrials.gov