Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity
NCT ID: NCT02216188
Last Updated: 2015-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2014-08-31
Brief Summary
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In addition, up to 8 patients will be offered participation within an untreated control group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A: AFFITOPE® PD01A + Adjuvant
one injection of 15µg AFFITOPE® PD01A/ adjuvanted
AFFITOPE® PD01A
s.c. injection
B: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/ adjuvanted
AFFITOPE® PD01A
s.c. injection
Control
Untreated control group
Control
Untreated control group
Interventions
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AFFITOPE® PD01A
s.c. injection
Control
Untreated control group
Eligibility Criteria
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Inclusion Criteria
* Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
* In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these
* Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
* Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator
Exclusion Criteria
* Participation in another clinical trial (except AFF008E) within 3 months before Visit 0
* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
* Autoimmune disease or allergy to components of the vaccine
* History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
* Active infectious disease
* Immunodeficiency
* Significant systemic illness or psychiatric illness
* Alcoholism or substance abuse
* Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation
* Venous status rendering it impossible to place an i.v. access
40 Years
68 Years
ALL
No
Sponsors
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Affiris AG
INDUSTRY
Responsible Party
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Principal Investigators
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Dieter Volc, Prim, Dr.
Role: PRINCIPAL_INVESTIGATOR
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Locations
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Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Vienna, Austria
Countries
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References
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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.
Other Identifiers
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2014-002489-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFFiRiS 008A
Identifier Type: -
Identifier Source: org_study_id
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