Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
Stopped early · Phase 4
Conditions studied: Relapsing-Remitting Multiple Sclerosis
In brief
The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).
Key facts
- Study ID
- NCT02342704
- Run by
- Biogen
- People needed
- 111
- Starts
- 2014-11-30
- Expected to finish
- 2016-05-18
- Last updated by the study team
- 2017-06-09
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Aurora, Colorado, United States
- Research Site — Colorado Springs, Colorado, United States
- Research Site — Port Charlotte, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Des Moines, Iowa, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Knoxville, Tennessee, United States
- Research Site — Round Rock, Texas, United States
- Research Site — San Antonio, Texas, United States
- Research Site — Seattle, Washington, United States
- Research Site — Tacoma, Washington, United States
- Research Site — Milwaukee, Wisconsin, United States
- Research Site — Camperdown, New South Wales, Australia
- Research Site — New Lambton Heights, New South Wales, Australia
- Research Site — Heidelberg, Victoria, Australia
- Research Site — Brno, Czechia
- Research Site — Brno, Czechia
- Research Site — Hradec Králové, Czechia
- Research Site — Jihlava, Czechia
- Research Site — Ostrava - Poruba, Czechia
- Research Site — Pardubice, Czechia
- Research Site — Prague, Czechia
- Research Site — Teplice, Czechia
- Research Site — Nîmes, Gard, France
- Research Site — Libourne, Gironde, France
Full record on ClinicalTrials.gov
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