Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis

PHASE4CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

May 6, 2015

Primary Completion Date

January 24, 2018

Study Completion Date

May 7, 2018

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Dimethyl fumarate

Dimethyl fumarate (Tecfidera®) treatment is initiated by daily administration of 120 mg Tecfidera® p.o. in the morning in week 0. At week 1, the dose is increased to 120 mg Tecfidera® p.o. twice daily, split into a morning and an evening dose. At week 2, the daily dose is further increased to 240 mg Tecfidera® p.o. in the morning and 120 mg Tecfidera® p.o. in the evening. Finally at week 3, the dose will be increased to the final daily dose of 240 mg Tecfidera® p.o. in the morning and 240 mg Tecfidera® p.o. in the evening and maintained throughout the study.

Trial Locations (6)

48149

University Hospital Muenster, Department of Neurology, Münster

49076

MVZ-Neurologie Klinikum Osnabrück GmbH, Osnabrück

53111

Neurologisches Studienzentrum Dr. Schmidt/Dr. Neudecker/ Dr. Viehbahn/Dr. Kronenberger, Bonn

55131

Klinik und Poliklinik für Neurologie, Universitätsklinikum Mainz, Mainz

60313

Neurologische Gemeinschaftspraxis im Bienenkorbhaus, Frankfurt am Main

69120

Neurologische Univ.-Klinik, Heidelberg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biogen

INDUSTRY

lead

University Hospital Muenster

OTHER