NCT00871780

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	BG00002 (natalizumab)

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-03-30
• Last updated: 2017-03-21
• Results posted: 2014-11-18

Locations

15 sites across 6 countries: Belgium, Mexico, Poland, Romania, Saudi Arabia, Ukraine