Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02270489
Study type Interventional
Source Affiris AG
Contact
Status Completed
Phase Phase 1
Start date December 11, 2014
Completion date April 18, 2017

See also
  Status Clinical Trial Phase
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT05788133 - The Role of Humanoid Robot in Neuropsychological Assessment and Cognitive Training. N/A
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Completed NCT03295786 - Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease Phase 1/Phase 2
Recruiting NCT04265482 - Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly
Not yet recruiting NCT02222779 - Quantification of Transition Metals N/A
Recruiting NCT01291550 - Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples N/A
Completed NCT01450891 - Health Technology Assessment of Diagnostic Approaches in Alzheimer's Disease N/A
Completed NCT01953523 - Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions N/A
Recruiting NCT06148233 - CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging N/A
Completed NCT03538522 - A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831 Phase 2
Completed NCT06251830 - Increasing Diagnosis Rates While Reducing Examination Time: Can MR Fingerprinting Deliver on Its Promise?
Recruiting NCT04472130 - Neurodegenerative Diseases Registry
Completed NCT03353207 - Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration
Completed NCT05095870 - Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS Neuropathies
Recruiting NCT05784090 - Correlation Between Melatonin Levels in Different Biological Fluids
Completed NCT02108769 - Yogic Breathing Changes Salivary Components N/A
Recruiting NCT05508789 - A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Phase 3
Recruiting NCT05235802 - Long-term Follow-up in Severe Traumatic Brain Injury
Recruiting NCT04820881 - Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury