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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002650-31 | EudraCT Number |
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This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in Vienna (Austria) will be involved. Each patient's participation will last 1 year.
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 | 4 injections of 15µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks |
|
| B: AFFITOPE® PD01A + Adjuvant | Experimental | 4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks |
|
| Control | Other | Untreated control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFFITOPE® PD01A | Biological | s.c. injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability/Safety |
| 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological | - Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein | 12 month |
| Clinical Activity |
|
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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 | 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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| Control | Other | Untreated control |
|
| 12 month |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |