The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial
This report presents the rationale and methodology of TOTEM RRMS, a French, phase 2, multicenter, randomized, placebo-controlled, and double-blind trial, which aims to prevent the progression of MS in men with low testosterone levels by administration of testosterone undecanoate, who were kept under natalizumab (Tysabri ®) to overcome the anti-inflammatory effect of testosterone. Forty patients will be randomized into two groups receiving either a testosterone treatment (Nebido®) or a matching placebo. The intervention period for each group will last 66 weeks (treatment will be injected at baseline, week 6, and then ev...
Source: Trials - June 28, 2020 Category: Research Source Type: clinical trials
Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis Interventions: Drug: Personalized extended interval dosing of natalizumab; Drug: Standard interval dosing Sponsors: VU University Medical Center; Stichting MS Research; Innovatiefonds Zorgverzekeraard Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 13, 2020 Category: Research Source Type: clinical trials
