Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis

NCT00324506 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-06-19

No results posted yet for this study

Summary

The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis. Safety will be assessed by virtue of changes in size and number of lesions on MRI scans.

Conditions

Interventions

DRUG

Mycophenolate Mofetil (CellCept)

Sponsors & Collaborators

  • Aspreva Pharmaceuticals

    collaborator INDUSTRY
  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Elliot M Frohman, MD/PhD · University of Texas, Southwestern Medical Center at Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT00324506 on ClinicalTrials.gov