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Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) — EMERA006  

Multiple System Atrophy Clinical Trial

Official title:
A Pilot Exploratory, Randomised, Placebo-controlled, Double Blinded, Cross-over , Phase 2a Study to Explore Efficacy and Safety of NBMI Treatment in Patients With Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA)

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

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