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Clinical Trial Summary

In total 20 subjects will be enrolled at one participating site -UMC Ljubljana. The 20 subjects will be treated with placebo and NBMI 300 mg in a cross-over design. In case of subject drop-outs, additional subjects may be enrolled as decided by the Sponsor, to allow for expected number of evaluable subjects in each group.


Clinical Trial Description

· The study's primary objective is: To explore the efficacy of 28 days NBMI treatment on motor and non-motor symptoms and heath related quality of life in patients with Progressive Supranuclear Palsy or Multiple Systems Atrophy disease. The study's secondary objectives are: - to explore safety and tolerability of 28 day NBMI treatment in patients with Progressive Supranuclear Palsy or Multiple Systems Atrophy. - to investigate the efficacy of NBMI daily oral administration for 28 days on fatigue in MSA and PSP patients, - to investigate the efficacy of NBMI daily oral administration for 28 days on depression in MSA and PSP patients. The study's exploratory aims are: - to explore the effect of NBMI treatment on patient's brain iron levels as evaluated by MRI imaging, - to explore the effect of NBMI on brain metabolism with FDG- PET- CT brain imaging, - to explore the pharmacokinetics of NBMI in patients with PSP or MSA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04184063
Study type Interventional
Source EmeraMed
Contact
Status Completed
Phase Phase 2
Start date September 16, 2019
Completion date June 30, 2021

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