TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 29, 2019

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection

Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)

DRUG

Placebo 4 mL Solution for Injection

Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)

PROCEDURE

MRI

Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)

BEHAVIORAL

Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities

BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)

BEHAVIORAL

Assessment of disability

EDSS (Baseline, week 30 and 66)

Trial Locations (5)

25000

RECRUITING

CHU de Besançon, Besançon

35000

RECRUITING

CHU de Rennes/Pontchaillou, Rennes

54000

RECRUITING

CHU Nancy, Nancy

67000

RECRUITING

CHRU de Strasbourg, Strasbourg

75013

RECRUITING

Hôpital Pitié-Salpêtrière, Paris

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Fédération Hospitalo-Universitaire NEUROGENYCS

UNKNOWN

collaborator

Grünenthal GmbH

INDUSTRY

lead

University Hospital, Strasbourg, France

OTHER