AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A
AFF008E:Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE® PD01A Applied During AFF008 in Patients With Parkinson's Disease.
2 other identifiers
observational
30
1 country
1
Brief Summary
AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedAugust 17, 2015
August 1, 2015
1.7 years
June 21, 2013
August 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Tolerability and Safety
These will be based on the following parameters: * Withdrawal criteria (continuation decision) Number of patients who withdraw due to adverse events Reason for withdrawal * Occurrence of any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study. * Occurrence of any adverse events possibly, probably or definitely related to the study vaccine
52 weeks
Secondary Outcomes (1)
Immunological and Clinical Efficacy
52 weeks
Study Arms (3)
15µg AFFITOPE® PD01A
Patients With Parkinson's Disease vaccinated with 4 injections of 15µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008
75µg AFFITOPE® PD01A
Patients With Parkinson's Disease vaccinated with 4 injections of 75µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008
Control group
Untreated control group
Eligibility Criteria
Only participants of AFF008 will be offered participation in AFF008E.
You may qualify if:
- Written informed consent signed and dated by the patient
- Participation in AFF008
You may not qualify if:
- History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
- Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiris AGlead
Study Sites (1)
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32
Vienna, 1080, Austria
Related Publications (1)
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.
PMID: 30741694DERIVED
Biospecimen
Analyzing patients' DNA (isolated out of whole blood) for polymorphisms in genes/regions like REP1 or alpha-synuclein to correlate results with the progression rate of the disease.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dieter Volc, Prim. Dr.
Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2013
First Posted
June 25, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2015
Last Updated
August 17, 2015
Record last verified: 2015-08