Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Vienna, 1080, Austria
NCT Number: NCT02618941
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.
In addition, up to 6 patients will be offered participation within an untreated control Group.
Looking for future studies?
Notify Me40 year–68 year
All sexes
Interventional
Phase 1
Vienna, 1080, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
s.c. injection
Time frame: 12 months
Time frame: 12 months
The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated.
Time frame: 12 months
Time frame: 12 months
Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)
Time frame: 12 months
Change in motor/non-motor symptoms over time
Time frame: 12 months
Change in non-motor PD symptoms over time
Time frame: 12 months
Change in non-motor PD symptoms over time
Time frame: 12 months
Change in non-motor PD symptoms over time
Affiris AG
Industry
Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03648905
Autonomic Failure, Autonomic Nervous System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01621581
Basal Ganglia Diseases, Brain Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT05699460
Autonomic Nervous System Diseases, Basal Ganglia Diseases
Irvine, California, United States
View Trial DetailsNCT07720869
Basal Ganglia Diseases, Brain Diseases
Baton Rouge, Louisiana, United States
View Trial Details