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Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT04184063•EmeraMed

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has clinically confirmed documented diagnosis of PSP or MSA, according to the current clinical criteria.
•2. Patient has a brain MRI finding consistent with the diagnosis of PSP or MSA at Screening.
•3. Patient is aged 40 years to 85 years inclusive at screening age.
•4. Patient is fluent in the local language and possesses sufficient auditory and visual capacities to allow neuropsychological testing.
•5. Patient and caregiver are able to read and understand informed consent.
•6. Patient is on a stable therapy for PSP, MSA for at least 1 month prior to screening visit.
•7. If the patient received i.v. amantadine treatment, the last infusion must have been administered at least 6 months prior to the screening (V01).
•8. Availability of a caregiver who sufficiently knows the patient and will be able to accompany the patient on the study visits and to participate in study assessments of the patient where required.
•9. Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal or have a negative result of serum hCG test at screening and apply to criteria no. 10.
•10. Female of childbearing potential can only participate in the study if willing to use acceptable, effective methods of contraception during the trial and for three month after the end of trial participation as defined in point 6.7. of this protocol.
+2 more criteria

Exclusion Criteria

•1. Known history or presence of clinically significant other neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
•2. Known or suspected allergy hypersensitivity or idiosyncratic reaction to NBMI or any other drug substances with similar activity.
•3. Patient has known contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation or other as judged by the Investigator.
•4. Patient has claustrophobia that could prevent MRI imaging
•5. History of drug or alcohol addiction requiring treatment.
•6. Patient who had previous chronic exposure (within one year before recruitment) to iron from taking preparations/medications for rising iron
•7. History of malabsorption within the last year or presence of clinically significant gastrointestinal disease or surgery that may affect drug bioavailability, including but not limited to cholecystectomy.
•8. Patient is ridden to bed.
•9. Presence of hepatic or renal dysfunction. (SGOT and SGPT and bilirubin \> X2 UNL. creatinine \> 1.5mg/dl)
•10. Female patient who is pregnant (serum hCG level consistent with pregnancy diagnosis); or breastfeeding.
+5 more criteria

Locations (1)

Ukc Ljubljana

Ljubljana, Slovenia

Key Dates

Start Date

September 16, 2019

Primary Completion Date

July 30, 2020

Completion Date

June 30, 2021

Last Updated

September 23, 2021

Enrollment

ACTUAL participants

Conditions

Progressive Supranuclear PalsyMultiple System Atrophy

Interventions

NBMI

DRUG

Placebo

OTHER

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RECRUITING

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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