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EMERA006
CompletedPhase 2Study 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)
Lead sponsor
Asset
NBMI
Listed sites
1
Recruiting sites
-
Enrollment
20
actual
Study population
Frontotemporal dementia
Key I/E criteria
•Age 40-85•MRI contraindications excluded
Primary endpoints
•Changes in Progressive Supranuclear Palsy rating Scale (PSPRS) individual•Mini-Mental State Examination (MMSE)•Changes in Unified Multiple System Atrophy Rating Scale (UMSARS) individual
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
11. Male patients must either be surgically sterile or he and his female spouse/partner who is of childbearing potential must be willing to use highly effective methods of contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study.
12. Patient provides written informed consent
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.
11. Participation in a clinical trial that involved administration of an investigational medicinal product within 90 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
12. Patient has a history with evidence of cerebrovascular disease (ischemic or haemorrhagic), or diagnosis of possible, probable or definite vascular Parkinsonism or dementia.
13. Have clinically significant abnormal laboratory values (e.g. liver enzymes)
14. Have clinically significant findings from a physical examination (e.g. fever)
15. Patient has claustrophobia that could prevent him from attending MRI imaging
Endpoints (21)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointChanges in FAB individual scales scores from baseline in PSP patients compared to placebo treatment
Time frame:through study completion, an average of 85 days
Mini-Mental State Examination (MMSE)
descriptive
Memory
1 endpointChanges in Non-Motor Symptoms assessment scale (NMSS) individual scale from baseline in MSA patients compared to placebo treatment
Time frame:through study completion, an average of 85 days
event count, event
Function / daily living
1 endpointChanges in Unified Multiple System Atrophy Rating Scale (UMSARS) individual scale from baseline in MSA patients compared to placebo treatment
Time frame:through study completion, an average of 85 days
descriptive
Behavior / neuropsychiatric
3 endpointsChanges in QOL individual scores from baseline by EQ-5D score in PSP patients compared to placebo treatment
Time frame:through study completion, an average of 85 days
descriptive
Changes in Beck's Depression Inventory (BDI) scale (MSA patients) score from Baseline V1 to V2 (D29) and to V4 (D57) compared to placebo treatment
Time frame:through study completion, an average of 85 days
threshold achievement, improvement
Changes in Geriatric depression scale (GDS) (PSP patients) score from Baseline - V1 to V2 (D29) and to V4 (D57) compared to placebo treatment
Time frame:through study completion, an average of 85 days
threshold achievement, improvement
Neuroimaging
2 endpointsChanges from baseline in brain metabolism as evaluated with Fluorodeoxyglucose Positron Emission Tomography (FDG PET) CT brain imaging compared to placebo treatment
Time frame:through study completion, an average of 85 days
descriptive
Changes from baseline in brain iron levels as detected with Magnetic Resonance Imaging (MRI) imaging methods compared to placebo treatment
Time frame:through study completion, an average of 85 days
descriptive
Caregiver / quality of life
2 endpointsChanges in QOL individual scores from baseline by MSA questionnaire in MSA patients
Time frame:through study completion, an average of 85 days
descriptive
Changes in QOL individual scores from baseline by MSA questionnaire in MSA patients using Visual Analog score
Time frame:through study completion, an average of 85 days
descriptive
Safety / tolerability / PK
8 endpointsFrequency, type and severity of adverse events compared to placebo treatment .
Time frame:through study completion, an average of 85 days
change from baseline, event
Pharmacokinetic parameters derived from plasma concentrations of NBMI: Maximum Plasma Concentration [Cmax]
Time frame:Day 56, 57
concentration, descriptive
Pharmacokinetic parameters derived from plasma concentrations of NBMI: AUC0-t
Time frame:Day 56, 57
concentration, descriptive
Pharmacokinetic parameters derived from plasma concentrations of NBMI: AUC0-∞
Time frame:Day 56, 57
concentration, descriptive
Pharmacokinetic parameters derived from plasma concentrations of NBMI: AUC%Extrap,obs
Time frame:Day 56, 57
concentration, descriptive
Pharmacokinetic parameters derived from plasma concentrations of NBMI: t1/2
Time frame:Day 56, 57
concentration, descriptive
Pharmacokinetic parameters derived from plasma concentrations of NBMI: λz
Time frame:Day 56, 57
concentration, descriptive
Pharmacokinetic parameters derived from plasma concentrations of NBMI: T max
Time frame:Day 56, 57
concentration, descriptive
Other (unclassified)
3 endpointsChanges in Progressive Supranuclear Palsy rating Scale (PSPRS) individual scales scores from baseline in PSP patients compared to placebo treatment
Time frame:through study completion, an average of 85 days
descriptive
Changes in Parkinson's Disease Fatigue Score (PFS) score from Baseline - V1 to V2 (D29) and V1 to V5 (D57) in PSP and MSA patients compared to placebo treatment
Time frame:through study completion, an average of 85 days
event count, event
Percentage of NBMI-treated patients who develop a response to NBMI.
Time frame:through study completion, an average of 85 days
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.