MedTrace Logo

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients

NCT00871780 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2017-03-21

Study results available
· View outcomes & findings →

Summary

The primary objective of the study is to evaluate the evolution of walking capacity as measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of therapy with natalizumab. The secondary objectives of this study are as follows:

* To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.
* To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all participants and in the subgroups of participants stratified by baseline EDSS.

Conditions

  • Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

BG00002 (natalizumab)

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Belgium
  • Mexico
  • Poland
  • Romania
  • Saudi Arabia
  • Ukraine

Study Locations

More Related Trials

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 NCT00871780 on ClinicalTrials.gov