Parkinson's Disease Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease
This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.
This is a first-in-human Phase 1 study to determine the safety, tolerability, and immunogenicity of UB-312 in healthy participants and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD. The study consists of two parts. Part A of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part B of the study will consist of two cohorts of participants with Parkinson's disease (PD). Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
| Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
| Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
| Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
| Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
| Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
| Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
| Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
| Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
| Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
| Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
| Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
| Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
| Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
| Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
| Terminated |
NCT02924194 -
Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease
|
N/A | |
| Completed |
NCT02939391 -
A Study of KW-6356 in Subjects With Early Parkinson's Disease
|
Phase 2 |