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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002489-54 | 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 AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.
In addition, up to 8 patients will be offered participation within an untreated control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: AFFITOPE® PD01A + Adjuvant | Experimental | one injection of 15µg AFFITOPE® PD01A/ adjuvanted |
|
| B: AFFITOPE® PD01A + Adjuvant | Experimental | one injection of 75µg AFFITOPE® PD01A/ adjuvanted |
|
| Control | Other | Untreated control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFFITOPE® PD01A | Biological | s.c. injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability |
| 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological | - Titer of antibodies specific for the immunizing peptide, KLH (keyhole limpet hemocyanin; carrier protein), aSynuclein (aSyn), bSyn, aggregated aSyn as assessed by ELlSA, FACS (or equivalent methods) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Activity |
| 6 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Volc, Prim, Dr. | Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna | Vienna | State of Vienna | 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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| Control | Other | Untreated control group |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |