Phase 1/2a Randomized Controlled Study for Treatment of Early- to Moderate Stage Multiple System Atrophy Patients With the Investigational Allogeneic Cell Therapy Product, hOMSC300
Purpose of this phase 1/2a study is to assess the safety and efficacy of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA) .
NCT05698017 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05698017/
A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants With Multiple System Atrophy
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).
NCT05696717 — MSA - Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/msa-multiple-system-atrophy/NCT05696717/
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy
This trial will the efficacy of KM-819 compared to placebo in subjects with MSA for slowing the progression of MSA.
NCT05695378 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05695378/
Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy
Multiple system atrophy (MSA) is a rare, rapidly progressive, and invariably fatal neurological condition characterized by autonomic failure, parkinsonism, and/or ataxia. There is no available treatment to slow or halt disease progression. The purpose of this study is to assess optimal dosing frequency, effectiveness and safety of adipose-derived autologous mesenchymal stem cells delivered into the spinal fluid of patients with MSA. Funding source: FDA Office of Orphan Product Development (OOPD), Mayo Clinic Executive Dean for Research Transformational Award, Mayo Clinic Regenerative Medicine, and Mayo Clinic Department of Neurology.
NCT05167721 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05167721/
Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Multiple System Atrophy, Parkinson's Disease and 4repeat Tauopathies
This is a non-interventional observational study designed to systematically record the results of routine laryngeal examinations and specific characteristics of dysphagia in patients with multiple system atrophy (MSA), Parkinson's disease (PD) and progressive supranuclear palsy (PSP) and related 4repeat tauopathies. The results of a fiberoptic / flexible endoscopic evaluation of swallowing (FEES) while performing a structured task protocol will be recorded. If available, laryngeal electromyography (EMG) results will also be recorded. In addition to the examination results, demographic and disease-specific data are collected, and two questionnaires, the Swallowing Disturbance Questionnaire for Parkinson's Disease (SDQ-PD) and the swallowing specific Quality Of Life Questionnaire (SWALQOL), are administered.
NCT04706234 — Parkinson Disease
Status: Recruiting
http://inclinicaltrials.com/parkinson-disease/NCT04706234/
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of ION464 Administered Intrathecally to Adults With Multiple System Atrophy
The primary objectives are to evaluate the safety and tolerability of multiple doses of ION464 administered via intrathecal (IT) injection (Part 1) and to evaluate the long-term safety and tolerability of ION464 (Part 2) in participants with multiple system atrophy (MSA). The secondary objectives are to evaluate the pharmacodynamic (PD) effect of ION464 on the level of a potential biomarker of target engagement (Parts 1 and 2) and to evaluate the pharmacokinetic (PK) profile of ION464 in serum (Part 1).
NCT04165486 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT04165486/
Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy
In this project, the investigators will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a double blind randomized design. Six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fMRI examinations before and after tDCS will be conducted. The treatment and placebo groups will be crossed over after one-month washout. The investigators will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is also crucial. The investigators aim to peep the myth of FOG in PD and MSA by the multi-modality approach and hope the study will benefit the long suffering patients.
NCT03721887 — Parkinson's Disease
Status: Recruiting
http://inclinicaltrials.com/parkinson-s-disease/NCT03721887/
Inosine 5'-Monophosphate to Raise of Serum Uric Acid Level in Patients With Multiple System Atrophy: a Multi-center, Randomized Controlled, Double Blind, Parallel Assigned Clinical Trial (IMPROVE MSA Study)
A purpose of the present study is to investigate the capability of serum uric acid elevation, safety, and tolerability of inosine 5'-monophosphate in patients with multiple system atrophy with multicenter, randomized, placebo controlled, parallel assigned design. This may provide the cornerstone for future extended trial in multiple system atrophy, a debilitating disease to date.
NCT03403309 — Multiple System Atrophy
Status: Completed
http://inclinicaltrials.com/multiple-system-atrophy/NCT03403309/
A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy
This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patients with early Multiple System Atrophy (MSA). In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A (with adjuvant) and 6 patients in the control group who will receive the reference substance (Placebo). Over a study duration of 52 weeks, the study participants will receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 30 to 75 years can participate in the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved. AFF009 is part of the project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
NCT02270489 — Multiple System Atrophy
Status: Completed
http://inclinicaltrials.com/multiple-system-atrophy/NCT02270489/
Defining Cognitive and Motor Phenotypes of Parkinson's Disease (PD) With Magnetoencephalography
Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans.
NCT02132052 — Parkinson Disease
Status: Completed
http://inclinicaltrials.com/parkinson-disease/NCT02132052/