Clinical Trials Logo
  1. Home
  2. Progressive Supranuclear Palsy
  3. NCT04184063

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
See also
  Status Clinical Trial Phase
Completed NCT03593512 - Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy N/A
Recruiting NCT03648905 - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Active, not recruiting NCT05699460 - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Recruiting NCT02897063 - Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Phase 1
Not yet recruiting NCT00758849 - Fipamezole in Neurogenic Orthostatic Hypotension Phase 2
Completed NCT01155492 - Increased Gut Permeability to Lipopolysaccharides (LPS) in Parkinson's Disease N/A
Recruiting NCT04431713 - Exenatide Once-weekly as a Treatment for Multiple System Atrophy Phase 2
Recruiting NCT05121012 - Synaptic Loss in Multiple System Atrophy
Terminated NCT03589976 - A Futility Trial of Sirolimus in Multiple System Atrophy Phase 2
Recruiting NCT04706234 - Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
Completed NCT00368199 - Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes N/A
Recruiting NCT04472130 - Neurodegenerative Diseases Registry
Recruiting NCT04876326 - Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy N/A
Recruiting NCT04680065 - GDNF Gene Therapy for Multiple System Atrophy Phase 1
Completed NCT03753763 - Safinamide for Multiple System Atrophy (MSA) Phase 2
Recruiting NCT04250493 - Insulin Resistance in Multiple System Atrophy N/A
Recruiting NCT06072105 - Medical Decision Making in Multiple System Atrophy N/A
Terminated NCT02149901 - Water and Sudafed in Autonomic Failure Early Phase 1
Terminated NCT00997672 - Lithium in Multiple System Atrophy Phase 2
Terminated NCT00547911 - Augmenting Effects of L-DOPS With Carbidopa and Entacapone Phase 1/Phase 2