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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004854-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFFITOPE® PD01A + Adjuvant | Experimental | one injection of 75µg AFFITOPE® PD01A/adjuvanted |
|
| Control | No Intervention | Untreated control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFFITOPE® PD01A | Biological | s.c. injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any Serious Adverse Events (SAE) that are related to the study drug | 12 months | |
| Number of patients who withdraw due to Adverse Events (AEs) | 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. | 12 months |
| Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological activity of AFFITOPE® vaccine PD01A | Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS Ia, II, III | Change in motor/non-motor symptoms over time | 12 months |
| PDQ39 | Change in non-motor PD symptoms over time | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Volc, Prim. Dr. | Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt | Vienna | 1080 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30741694 | Derived | McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| PD NMS | Change in non-motor PD symptoms over time | 12 months |
| Cognitive scales | Change in non-motor PD symptoms over time | 12 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |