Trials / Completed
CompletedNCT04184063
Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- EmeraMed · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBMI | NBMI active treatment |
| OTHER | Placebo | Placebo for comparison |
Timeline
- Start date
- 2019-09-16
- Primary completion
- 2020-07-30
- Completion
- 2021-06-30
- First posted
- 2019-12-03
- Last updated
- 2021-09-23
Locations
1 site across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT04184063. Inclusion in this directory is not an endorsement.